Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01056718
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2010-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068577', 'term': 'Nebivolol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Denise.Janosik@mercy.net', 'phone': '314-251-3920', 'title': 'Denise Janosik, MD', 'organization': 'Mercy Hospital East Communities'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There was no placebo control. All patients received nebivolol and served as their own control before and after treatment. This study had a small study population and short duration.'}}, 'adverseEventsModule': {'timeFrame': 'Patients were monitored for 10 weeks for any adverse side effects resulting in discontinuation or decrease in nebivolol dosage after the titration period. They were also monitored for cardiovascular events during the treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Starting on 5 mg of Nebivolol Then Titrated', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resting Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'spread': '17', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Exercise Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '419', 'spread': '180', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Metabolic Equivalent (METS) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '3.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.', 'unitOfMeasure': 'METS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.078', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Stress Systolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'spread': '26', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.186', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Stress Diastolic BP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '17', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'Beats per Minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stress Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '24', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.06', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'Beats per Minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting EF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'unitOfMeasure': 'Percent of LV end diastolic volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stress EF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'Percent of LV end diastolic volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Stroke Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '14', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.85', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stress Stroke Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '16', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.40', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 week', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.64', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 week', 'unitOfMeasure': 'L per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stress Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.49', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 week', 'unitOfMeasure': 'L per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LV End Diastolic Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.47', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 week', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LV End Systolic Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.55', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 week', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LV Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '167', 'spread': '47', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=0.64', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 week', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Inflow (E) Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '21', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Inflow (A) Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'spread': '23', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.526', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mitral Valve E/A Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '0.31', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'description': 'mitral valve doppler E velocity to A velocity', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mitral Valve Deceleration Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '227', 'spread': '55', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.925', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Mitral Valve Tissue Doppler Velocity (e')", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Mitral Valve Tissue Doppler Velocity (a')", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.458', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "E/e' Ratio", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.561', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulmonary Vein Peak Systolic Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.734', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulmonary Vein Peak Diastolic Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '16', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '=.129', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 Week', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebivolol Treatment', 'description': 'all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks', 'description': 'Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the "best imaginable health state" and 0 is the "worst imaginable health state".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nebivolol Treatment', 'description': '10 week open label nebivolol treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Ischemia on baseline stress test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruited from the outpatient office at Mercy St. Louis between January 2010 and August 2012. The inclusion criteria were new or established hypertension as defined by serial BP measurements greater than or equal to 140/90 and evidence of left ventricular (LV) diastolic dysfunction as defined by a routine Doppler within a year of enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nebivolol Treatment', 'description': 'All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.\n\nNebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Systolic BP', 'classes': [{'categories': [{'measurements': [{'value': '145', 'spread': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Exercise Duration', 'classes': [{'categories': [{'measurements': [{'value': '385', 'spread': '174', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Metabolic Equivalent', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '3.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'One MET is defined as 3.5 mL 02 uptake/kg per minute', 'unitOfMeasure': 'Mets', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Diastolic BP', 'classes': [{'categories': [{'measurements': [{'value': '79', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Peak Stress Systolic BP', 'classes': [{'categories': [{'measurements': [{'value': '178', 'spread': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Peak Stress Diastolic BP', 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats per Minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stress Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats per Minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Ejection Fraction (EF)', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Ejection fraction = LV end diastolic volume - LV end systolic volume divided by LV end diastolic volume X 100', 'unitOfMeasure': 'Percent of LV end diastolic volume', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stress EF', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent of LV end diastolic volume', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Stroke Volume', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stress Stroke Volume', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Cardiac Output', 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stress Cardiac Output', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '2.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV End Diastolic Diameter', 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV End Systolic Diameter', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LV Mass', 'classes': [{'categories': [{'measurements': [{'value': '163', 'spread': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mitral Valve Inflow (E) Velocity', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm/s', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mitral Valve Inflow (A) Velocity', 'classes': [{'categories': [{'measurements': [{'value': '91', 'spread': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm/s', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mitral Valve E/A Ratio', 'classes': [{'categories': [{'measurements': [{'value': '.86', 'spread': '.18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mitral valve doppler E velocity to A velocity', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mitral Valve Deceleration Time', 'classes': [{'categories': [{'measurements': [{'value': '229', 'spread': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Mitral Valve Tissue Doppler Velocity (e')", 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '1.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm/s', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Mitral Valve Tissue Doppler Velocity (a')", 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '2.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm/s', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "E/e' Ratio", 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '4.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Mitral Valve E velocity to tissue doppler e' velocity", 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulmonary Vein Peak Systolic Velocity', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm/s', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulmonary Vein Peak Diastolic Velocity', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm/s', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of Life', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Subjects completed an EuroQol (EQ-SD) Quality of Life questionnaire which is a standardized measure of health status developed by the EuroQol group as a simple general measure of health. The EuroQol, records the subject\'s self reported assessment of his/her overall health on a vertical, visual analogue scale where 100 is "the best imaginable health state" and 0 is the "worst imaginable health state".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2010-01-25', 'resultsFirstSubmitDate': '2015-12-16', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-19', 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting Systolic BP', 'timeFrame': '10 Weeks'}, {'measure': 'Exercise Duration', 'timeFrame': '10 Weeks'}, {'measure': 'Metabolic Equivalent (METS) Level', 'timeFrame': '10 Weeks', 'description': 'METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.'}], 'secondaryOutcomes': [{'measure': 'Diastolic BP', 'timeFrame': '10 Week'}, {'measure': 'Peak Stress Systolic BP', 'timeFrame': '10 Week'}, {'measure': 'Peak Stress Diastolic BP', 'timeFrame': '10 Week'}, {'measure': 'Resting Heart Rate', 'timeFrame': '10 Week'}, {'measure': 'Stress Heart Rate', 'timeFrame': '10 Week'}, {'measure': 'Resting EF', 'timeFrame': '10 Weeks'}, {'measure': 'Stress EF', 'timeFrame': '10 Week'}, {'measure': 'Resting Stroke Volume', 'timeFrame': '10 weeks'}, {'measure': 'Stress Stroke Volume', 'timeFrame': '10 week'}, {'measure': 'Resting Cardiac Output', 'timeFrame': '10 week'}, {'measure': 'Stress Cardiac Output', 'timeFrame': '10 week'}, {'measure': 'LV End Diastolic Diameter', 'timeFrame': '10 week'}, {'measure': 'LV End Systolic Diameter', 'timeFrame': '10 week'}, {'measure': 'LV Mass', 'timeFrame': '10 week'}, {'measure': 'Mitral Valve Inflow (E) Velocity', 'timeFrame': '10 Week'}, {'measure': 'Mitral Valve Inflow (A) Velocity', 'timeFrame': '10 Week'}, {'measure': 'Mitral Valve E/A Ratio', 'timeFrame': '10 Week', 'description': 'mitral valve doppler E velocity to A velocity'}, {'measure': 'Mitral Valve Deceleration Time', 'timeFrame': '10 Week'}, {'measure': "Mitral Valve Tissue Doppler Velocity (e')", 'timeFrame': '10 Week'}, {'measure': "Mitral Valve Tissue Doppler Velocity (a')", 'timeFrame': '10 Week'}, {'measure': "E/e' Ratio", 'timeFrame': '10 Week'}, {'measure': 'Pulmonary Vein Peak Systolic Velocity', 'timeFrame': '10 Week'}, {'measure': 'Pulmonary Vein Peak Diastolic Velocity', 'timeFrame': '10 Week'}, {'measure': 'Quality of Life', 'timeFrame': '10 Weeks', 'description': 'Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the "best imaginable health state" and 0 is the "worst imaginable health state".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diastolic Function', 'Nebivolol'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '10109801', 'type': 'RESULT', 'citation': 'EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to effectively treat hypertension in subjects with either known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due to the unique properties of nebivolol, it is hypothesized that there will be improvements in left ventricular (LV) systolic and diastolic function manifesting as increase exercise capacity in this patient population with primarily LV diastolic dysfunction. The present study was performed to determine the effects of nebivolol on blood pressure, exercise tolerance and parameters of left ventricular systolic and diastolic function in a group of hypertensive patients with echocardiographic evidence diastolic dysfunction.', 'detailedDescription': 'Prior to the initiation of Nebivolol and after 10 weeks of Nebivolol therapy, subjects underwent a resting 2D echocardiogram including routine sampling of mitral valve (MV) inflow and LV tissue Doppler imaging as well as a symptom limited exercise treadmill stress test with echocardiographic imaging. Primary endpoints were 1) changes in systolic blood pressure before and after 10 weeks of treatment and 2) changes in exercise capacity as determined by exercise duration and metabolic equivalent (MET) level before and after treatment. Secondary endpoints were changes in exercise hemodynamics and Doppler echocardiographic parameters of LV systolic and diastolic function and quality of life before and after 10 weeks of nebivolol treatment. Subjects completed an EuroQol (EQ-SD) Quality of Life questionnaire which is a standardized measure of health status developed by the EuroQol group as a simple general measure of health at baseline and at conclusion of the 10 week trial period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis (new or established) hypertension, defined by serial measurements \\>/= 140/90\n* Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler\n\nExclusion Criteria:\n\n* Severe bronchospastic disease/ reactive airway disease\n* Inability to tolerate beta blocker therapy including: \\>1st degree atrioventricular (AV) block, symptomatic hypotension, symptomatic bradycardia,\n* Subjects with physical limitations that would prevent them from participating in an exercise treadmill test\n* Age \\<18 or \\>90 years\n* Those with life expectancy \\<1 year\n* Subjects with class III/IV New York Heart Association (NYHA) heart failure symptoms\n* Chronic Kidney Disease 3 or greater (CrCl \\<30 cc/min)\n* Subjects with active ischemia or evidence of ischemia on initial stress echocardiography'}, 'identificationModule': {'nctId': 'NCT01056718', 'briefTitle': 'Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Research'}, 'officialTitle': 'Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function', 'orgStudyIdInfo': {'id': 'BYS-MD-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nebivolol treatment', 'description': '10 week open label nebivolol treatment.', 'interventionNames': ['Drug: Nebivolol']}], 'interventions': [{'name': 'Nebivolol', 'type': 'DRUG', 'description': "Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. The dose was titrated by doubling the previous dosage to achieve BP less than or equal to 130/80 mm Hg at 2 weeks and 4 weeks. The mean dose of nebivolol used week 4 through week 10 was 7.8 mg. It should be noted that nebivolol was added to the subject's existing stable antihypertensive regimen which included a mean of 2 other medications.", 'armGroupLabels': ['Nebivolol treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Mercy Cardiovascular Research", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'James A. Stokes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. John's Mercy Heart & Vascular"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist Mercy Hospital', 'investigatorFullName': 'James Stokes, MD', 'investigatorAffiliation': 'Mercy Research'}}}}