Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-30 @ 5:01 PM
Study NCT ID:
NCT01411735
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2011-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004656', 'term': 'Enalapril'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-05', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity and aortic distensibility', 'timeFrame': '9 months', 'description': 'MRI and expired gas analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction', 'Heart Failure, Congestive']}, 'descriptionModule': {'briefSummary': 'BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy.\n\nMETHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI; Doppler-echocardiography; and vascular ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants will be 60 years of age or older.\n\nExclusion Criteria:\n\n1. systolic dysfunction\n2. patients with evidence of significant ischemic or valvular heart disease\n3. chronic pulmonary disease.\n\nParticipants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. They also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests.\n\nFinal eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.'}, 'identificationModule': {'nctId': 'NCT01411735', 'acronym': 'PIE-I', 'briefTitle': 'Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure', 'orgStudyIdInfo': {'id': 'R01AG018915-01', 'link': 'https://reporter.nih.gov/quickSearch/R01AG018915-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril', 'description': '2.5mg titrated up to 10mg- twice daily', 'interventionNames': ['Drug: Enalapril']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '2.5 mg titrate up to 10mg twice daily placebo comparator', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Enalapril', 'type': 'DRUG', 'description': '2.5mg titrated up to 10mg twice daily', 'armGroupLabels': ['Enalapril']}, {'name': 'placebo', 'type': 'DRUG', 'description': '2.5mg titrated up to 10mg twice daily.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dalane W Kitzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine-Cardiology Section'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}