Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 8:39 AM
Study NCT ID:
NCT00389168
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2006-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Irbesartan and Atenolol in Hypertensive Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006332', 'term': 'Cardiomegaly'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077405', 'term': 'Irbesartan'}, {'id': 'D001262', 'term': 'Atenolol'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.kahan@ds.se', 'phone': '+46 8 123 568 61', 'title': 'Thomas Kahan, MD', 'organization': 'Karolinska Institutet, Stockholm, Sweden'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The entire duration of study: that is 4-6 weeks of single-blinded placebo run-in, 48 weeks of double-blinded medication, and 4 weeks following completion of the study.', 'description': 'Defied and reported according to study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Irbesratan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg', 'otherNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'inadequate blood pressure reduction', 'notes': 'None of withdrawals were considered likely related to the drugs studied.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'events were not documented specifically in the records available', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment period was baseline to 48 weeks', 'description': 'Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Left Ventricular Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '4'}, {'value': '-9', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '-6'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-12', 'upperLimit': '0'}, {'value': '-14', 'groupId': 'OG001', 'lowerLimit': '-22', 'upperLimit': '-6'}]}]}, {'title': '48 weeks', 'categories': [{'measurements': [{'value': '-14', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '9'}, {'value': '-26', 'groupId': 'OG001', 'lowerLimit': '-34', 'upperLimit': '-18'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m\\^2).', 'unitOfMeasure': 'g/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on echocardiography is not always available at all time points and for all participants. This is reflected by the number of observations, which sometimes are less than the number of participants.'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Diastolic Function Assessed by the E/A Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.3', 'groupId': 'OG000', 'lowerLimit': '-18.5', 'upperLimit': '-14.0'}, {'value': '-18.8', 'groupId': 'OG001', 'lowerLimit': '-21.4', 'upperLimit': '-16.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}], 'classes': [{'title': 'Weel 12', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '4.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.1'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.7'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '0.4'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.', 'unitOfMeasure': 'pmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects on Carotid Artery Wall Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'OG001', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Changes in common carotid artery intima-media thickness, assessed by ultrasonography.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'FG001', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve \\< 140/90 mm Hg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Multicenter Swedish study. Patients with primary hypertension and left ventricular (LV) hypertrophy.', 'preAssignmentDetails': 'All participants received a placebo washout period during 4 weeks at the beginning of the study.\n\nOne patient of the 115 included was during the course of the study diagnosed with Mb Conn (adrenal tumor causing endocrine secondary hypertension). This patient was excluded from all analyses. Thus, there are 114 patients included in the dataset.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atenolol', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'BG001', 'title': 'Irbesartan', 'description': 'A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve \\< 140/90 mm Hg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '10', 'groupId': 'BG000'}, {'value': '54', 'spread': '8', 'groupId': 'BG001'}, {'value': '54', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '1997-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-03', 'studyFirstSubmitDate': '2006-10-17', 'resultsFirstSubmitDate': '2012-08-19', 'studyFirstSubmitQcDate': '2006-10-17', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-03', 'studyFirstPostDateStruct': {'date': '2006-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1997-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Left Ventricular Mass Index', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m\\^2).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': 'Treatment period was baseline to 48 weeks', 'description': 'Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.'}, {'measure': 'Left Ventricular Diastolic Function Assessed by the E/A Ratio', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks'}, {'measure': 'Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.'}, {'measure': 'Effects on Carotid Artery Wall Thickness', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Changes in common carotid artery intima-media thickness, assessed by ultrasonography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Cardiac hypertrophy', 'Angiotensin', 'Human'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '11403367', 'type': 'RESULT', 'citation': 'Malmqvist K, Kahan T, Edner M, Held C, Hagg A, Lind L, Muller-Brunotte R, Nystrom F, Ohman KP, Osbakken MD, Ostergern J. Regression of left ventricular hypertrophy in human hypertension with irbesartan. J Hypertens. 2001 Jun;19(6):1167-76. doi: 10.1097/00004872-200106000-00023.'}, {'pmid': '12172314', 'type': 'RESULT', 'citation': 'Nystrom F, Malmqvist K, Ohman KP, Kahan T. Nurse-recorded and ambulatory blood pressure predicts treatment-induced reduction of left ventricular hypertrophy equally well in hypertension: results from the Swedish irbesartan left ventricular hypertrophy investigation versus atenolol (SILVHIA) study. J Hypertens. 2002 Aug;20(8):1527-33. doi: 10.1097/00004872-200208000-00015.'}, {'pmid': '12423712', 'type': 'RESULT', 'citation': 'Malmqvist K, Kahan T, Edner M, Bergfeldt L. Comparison of actions of irbesartan versus atenolol on cardiac repolarization in hypertensive left ventricular hypertrophy: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation Versus Atenolol (SILVHIA). Am J Cardiol. 2002 Nov 15;90(10):1107-12. doi: 10.1016/s0002-9149(02)02777-7.'}, {'pmid': '14639093', 'type': 'RESULT', 'citation': 'Malmqvist K, Ohman KP, Lind L, Nystrom F, Kahan T. Long-term effects of irbesartan and atenolol on the renin-angiotensin-aldosterone system in human primary hypertension: the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA). J Cardiovasc Pharmacol. 2003 Dec;42(6):719-26. doi: 10.1097/00005344-200312000-00005.'}, {'pmid': '16942935', 'type': 'RESULT', 'citation': 'Muller-Brunotte R, Kahan T, Malmqvist K, Ring M, Edner M. Tissue velocity echocardiography shows early improvement in diastolic function with irbesartan and atenolol therapy in patients with hypertensive left ventricular hypertrophy. Results form the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs Atenolol (SILVHIA). Am J Hypertens. 2006 Sep;19(9):927-36. doi: 10.1016/j.amjhyper.2006.02.009.'}, {'pmid': '17444886', 'type': 'RESULT', 'citation': 'Mortsell D, Malmqvist K, Held C, Kahan T. Irbesartan reduces common carotid artery intima-media thickness in hypertensive patients when compared with atenolol: the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA) study. J Intern Med. 2007 May;261(5):472-9. doi: 10.1111/j.1365-2796.2007.01775.x.'}, {'pmid': '17637792', 'type': 'RESULT', 'citation': 'Malmqvist K, Kahan T, Edner M, Bergfeldt L. Cardiac repolarization and its relation to ventricular geometry and rate in reverse remodelling during antihypertensive therapy with irbesartan or atenolol: results from the SILVHIA study. J Hum Hypertens. 2007 Dec;21(12):956-65. doi: 10.1038/sj.jhh.1002250. Epub 2007 Jul 19.'}, {'pmid': '17762662', 'type': 'RESULT', 'citation': 'Muller-Brunotte R, Kahan T, Lopez B, Edner M, Gonzalez A, Diez J, Malmqvist K. Myocardial fibrosis and diastolic dysfunction in patients with hypertension: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA). J Hypertens. 2007 Sep;25(9):1958-66. doi: 10.1097/HJH.0b013e3282170ada.'}, {'pmid': '18464745', 'type': 'RESULT', 'citation': 'Kurland L, Hallberg P, Melhus H, Liljedahl U, Hashemi N, Syvanen AC, Lind L, Kahan T. The relationship between the plasma concentration of irbesartan and the antihypertensive response is disclosed by an angiotensin II type 1 receptor polymorphism: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs. Atenolol (SILVHIA) Trial. Am J Hypertens. 2008 Jul;21(7):836-9. doi: 10.1038/ajh.2008.190. Epub 2008 May 8.'}, {'pmid': '19486119', 'type': 'RESULT', 'citation': 'Liljedahl S, Kahan T, Lind L, Arnlov J. The effects of antihypertensive treatment on the doppler-derived myocardial performance index in patients with hypertensive left ventricular hypertrophy: results from the Swedish irbesartan in left ventricular hypertrophy investigation versus atenolol (SILVHIA). Echocardiography. 2009 Aug;26(7):753-8. doi: 10.1111/j.1540-8175.2008.00886.x.'}, {'pmid': '14704728', 'type': 'RESULT', 'citation': 'Muller-Brunotte R, Kahan T, Malmqvist K, Edner M; Swedish ibesartan left ventricular hypertrophy investigation vs atenolol (SILVHIA). Blood pressure and left ventricular geometric pattern determine diastolic function in hypertensive myocardial hypertrophy. J Hum Hypertens. 2003 Dec;17(12):841-9. doi: 10.1038/sj.jhh.1001622.'}, {'pmid': '15716707', 'type': 'RESULT', 'citation': 'Muller-Brunotte R, Edner M, Malmqvist K, Kahan T. Irbesartan and atenolol improve diastolic function in patients with hypertensive left ventricular hypertrophy. J Hypertens. 2005 Mar;23(3):633-40. doi: 10.1097/01.hjh.0000160222.17092.b8.'}, {'pmid': '24084214', 'type': 'RESULT', 'citation': 'Jekell A, Malmqvist K, Wallen NH, Mortsell D, Kahan T. Markers of inflammation, endothelial activation, and arterial stiffness in hypertensive heart disease and the effects of treatment: results from the SILVHIA study. J Cardiovasc Pharmacol. 2013 Dec;62(6):559-66. doi: 10.1097/FJC.0000000000000017.'}, {'pmid': '14700505', 'type': 'RESULT', 'citation': 'Kurland L, Liljedahl U, Karlsson J, Kahan T, Malmqvist K, Melhus H, Syvanen AC, Lind L. Angiotensinogen gene polymorphisms: relationship to blood pressure response to antihypertensive treatment. Results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs Atenolol (SILVHIA) trial. Am J Hypertens. 2004 Jan;17(1):8-13. doi: 10.1016/j.amjhyper.2003.09.009.'}]}, 'descriptionModule': {'briefSummary': 'The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.\n\nThis projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.', 'detailedDescription': 'We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h ambulatory blood pressure monitoring monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 ys old\n* Male or female with no child bearing potential\n* Seated blood pressure diastolic 90-115 mm Hg\n* Left ventricular mass above 131 g/m2 for men, above 100 g/m2 for women\n* Informed consent\n\nExclusion Criteria:\n\n* Coronary artery disease, heart failure or other significant cardiac disorder\n* Cerebrovascular accident within the past 6 months\n* A seated systolic blood pressure above 200 mm Hg\n* Significant renal disease, collagen or vascular disease, or gastrointestinal condition\n* Significant allergy or intolerance to study drug\n* Alcohol or drug abuse\n* Uncontrolled diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT00389168', 'acronym': 'SILVHIA', 'briefTitle': 'Irbesartan and Atenolol in Hypertensive Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Randomized, Double-blind Evaluation of the Effects of Irbesartan and Atenolol on Cardiovascular Structure and Function in Subjects With Hypertension and Left Ventricular Hypertrophy', 'orgStudyIdInfo': {'id': 'CV131-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irbesartan', 'description': 'Irbesartan per os titrated to 300 mg od, 48 weeks', 'interventionNames': ['Drug: Irbesartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atenolol', 'description': 'Atenolol per os titrated to 100 mg od, 48 weeks', 'interventionNames': ['Drug: Atenolol']}], 'interventions': [{'name': 'Irbesartan', 'type': 'DRUG', 'otherNames': ['Aprovel'], 'description': 'Titrated to 300 mg od, 48 weeks.', 'armGroupLabels': ['Irbesartan']}, {'name': 'Atenolol', 'type': 'DRUG', 'otherNames': ['Tenormin'], 'description': 'Titrated to 100 mg od, 48 weeks.', 'armGroupLabels': ['Atenolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet, Daprtment of Clinical Sciences, Danderyd Hospital, Cardiovascular Research Laboratory', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Thomas Kahan, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, SE-182 88 Stockholm, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Swedish Heart Lung Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Principal investigator and Study Chair', 'investigatorFullName': 'Thomas Kahan', 'investigatorAffiliation': 'Karolinska Institutet'}}}}