Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-01 @ 12:19 AM
Study NCT ID:
NCT02693002
Status:
TERMINATED
Last Update Posted:
2018-08-08
First Post:
2016-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Estrogen Diastolic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C418365', 'term': 'estradiol, norethindrone drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gretchen.wells@uky.edu', 'title': 'Dr. Gretchen Wells, PI', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to limited enrollment, there were too few participants to draw statistically meaningful conclusions from collected data.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Hormone Replacement Therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks\n\nEstradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks\n\nPlacebo: inactive ingredient', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vaginal Bleeding', 'notes': 'Patient was randomized on 7/6/16. She developed vaginal bleeding on 8/7/16. Vaginal bleeding ICFinformed consent form. The patient underwent evaluation by primary care provider, stopped drug, and was withdrawn from the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diastolic Function Assessed by Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hormone Replacement Therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks\n\nEstradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks\n\nPlacebo: inactive ingredient'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in diastolic function as assessed by echocardiography from baseline to 12 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.'}, {'type': 'SECONDARY', 'title': 'Activity Level Assessed by Duke Activity Status Index (DASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hormone Replacement Therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks\n\nEstradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks\n\nPlacebo: inactive ingredient'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a "No" answer or awarded a fixed number of points ranging from 1.75-8 for a "Yes" answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hormone Replacement Therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks\n\nEstradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks\n\nPlacebo: inactive ingredient'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates "Not true of me" and 5 indicates an answer of "mostly true". Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for "Occupational", 31 points for "Health", 28 points for "Emotional" and 15 points for "Sexual" for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.'}, {'type': 'SECONDARY', 'title': 'B-type Natriuretic Peptide (BNP) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hormone Replacement Therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks\n\nEstradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks\n\nPlacebo: inactive ingredient'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hormone Replacement Therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks\n\nEstradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks\n\nPlacebo: inactive ingredient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hormone Replacement Therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks\n\nEstradiol/Norethindrone acetate: Estradiol/Norethindrone acetate 1mg/0.5 mg'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks\n\nPlacebo: inactive ingredient'}, {'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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Enrollment goals not being met', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2016-02-23', 'resultsFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-13', 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diastolic Function Assessed by Echocardiography', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in diastolic function as assessed by echocardiography from baseline to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Activity Level Assessed by Duke Activity Status Index (DASI)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a "No" answer or awarded a fixed number of points ranging from 1.75-8 for a "Yes" answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks.'}, {'measure': 'Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates "Not true of me" and 5 indicates an answer of "mostly true". Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for "Occupational", 31 points for "Health", 28 points for "Emotional" and 15 points for "Sexual" for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time.'}, {'measure': 'B-type Natriuretic Peptide (BNP) Levels', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).', 'detailedDescription': 'This preliminary, feasibility study will randomize 28 peri-menopausal women to either hormone replacement therapy or placebo for 12 weeks. Prior to randomization, each participant will undergo echocardiography, measurements of activity using the Duke Activity Status Index, measurements of quality of life and laboratory data, including b-type natriuretic peptide (BNP) measurements. Following the intervention for 12 weeks, these measurements will all be repeated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.\n\nExclusion Criteria:\n\n* History of hysterectomy, oophorectomy or both\n* History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis\n* History of bone disease including non-traumatic vertebral fractures on radiography\n* Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C \\>8, uncontrolled hypertension defined as a systolic blood pressure \\>160 mmHg, awaiting organ transplant)\n* Previous or current cancer, excluding basal cell carcinoma\n* Previous or current thromboembolic disease\n* Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)\n* Current or previous use of HRT within the past 3 months\n* Current or recent (\\<12 months) substance abuse, including tobacco use\n* No drug interactions with HRT\n* No racial or ethnic groups will be excluded'}, 'identificationModule': {'nctId': 'NCT02693002', 'briefTitle': 'Estrogen Diastolic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Heart Failure Prevention for Women: Preservation of Cardiac Function in the Peri-Menopausal Woman Through Hormone Therapy', 'orgStudyIdInfo': {'id': '15-0798-F6A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hormone replacement therapy', 'description': 'Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks', 'interventionNames': ['Drug: Estradiol/Norethindrone acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inert ingredients by mouth oral daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Estradiol/Norethindrone acetate', 'type': 'DRUG', 'otherNames': ['Activella'], 'description': 'Estradiol/Norethindrone acetate 1mg/0.5 mg', 'armGroupLabels': ['Hormone replacement therapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'inactive ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Gretchen L Wells, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data will be provided to participants of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gretchen Wells', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gretchen Wells', 'investigatorAffiliation': 'University of Kentucky'}}}}