Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05174351
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in KCCQ-23 score', 'timeFrame': 'Baseline and after 4 weeks of beta blocker discontinuation', 'description': 'Kansa city cardiomyopathy questionnaire (KCCQ-23)- self-administered, 23-item. questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. Scores are transformed to a range of 0-100, where higher scores reflect better health status.'}], 'secondaryOutcomes': [{'measure': 'Changes in cardiac mechanics by echocardiography', 'timeFrame': 'Baseline and after 4 weeks of beta blocker discontinuation', 'description': "Echocardiographic E/e' ratio"}, {'measure': 'Changes in biomarker', 'timeFrame': 'Baseline and after 4 weeks of beta blocker discontinuation', 'description': 'changes from baseline in BNP level (pg/mL) after 4 weeks of beta blocker discontinuation'}, {'measure': '6 minute walk test', 'timeFrame': 'Baseline and after 4 weeks of beta blocker discontinuation', 'description': 'The distance (meters) covered over a time of 6 minutes. A greater distance indicates a better exercise capacity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFpEF', 'Beta-blocker', 'echocardiogram', '6MWT'], 'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'This is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 HFpEF patients.', 'detailedDescription': 'This is a prospective pilot study to evaluate changes before and 4 weeks(+/- 1 week) after beta-blocker withdrawal in 30 HFpEF patients. The study involves 2 visits that are 4 weeks apart. The first study visit will occur at a standard of care clinic visit and the second visit will be a research visit to fill out questionnaires and perform the limited echocardiogram. No long term follow up beyond the 2nd visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable HFpEF patients with NYHA Class II-III or elevated BNP ≥100\n* N=30 (Target: 30).\n* Age: 50 \\~ 80 years.\n* ECHO evidence of EF ≥50% and Grade 2 or 3 diastolic dysfunction.\n* Chronic loop diuretic use\n* Currently on beta-blocker\n\nExclusion Criteria:\n\n* Beta blocker was prescribed for treating other cardiac conditions such as atrial fibrillation or coronary artery disease.\n* Heart rate \\> 100 bpm\n* Recent hospitalization due to HF within 3 months\n* Non-English speaker'}, 'identificationModule': {'nctId': 'NCT05174351', 'acronym': 'HFpEF-BB', 'briefTitle': 'Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': '22-145-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HFpEF patients', 'description': 'HFpEF patient who are currently taking beta blockers', 'interventionNames': ['Other: beta blocker discontinuation']}], 'interventions': [{'name': 'beta blocker discontinuation', 'type': 'OTHER', 'description': 'beta blocker discontinuation', 'armGroupLabels': ['HFpEF patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kai Chen, MD, PhD', 'role': 'CONTACT', 'email': 'kachen@uchc.edu', 'phone': '860-679-3343'}], 'facility': 'UConn Health / John Dempsey Hospital', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'centralContacts': [{'name': 'Kai Chen, MD,PhD', 'role': 'CONTACT', 'email': 'kachen@uchc.edu', 'phone': '860-679-3343'}], 'overallOfficials': [{'name': 'Kai Chen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christopher Pickett', 'investigatorAffiliation': 'UConn Health'}}}}