Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 8:33 AM
Study NCT ID:
NCT06150950
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080039', 'term': 'Univentricular Heart'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At enrollment, participants will be randomized in a 1:1 ratio to cardiac rehabilitation or usual care using randomly permuted blocks of 2, 4, and 6. The randomization will be stratified by study site and time from Fontan palliation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory outcome: number of participants with exercise-induced clinical ailment', 'timeFrame': '120 days (+/- 45 days) post-randomization', 'description': 'Sustained arrhythmia or hemodynamic change necessitating hospitalization, heart failure hospitalization, or all-cause death within 30 days of completion of cardiac rehabilitation'}], 'primaryOutcomes': [{'measure': 'Average daily step count', 'timeFrame': '120 days (+/- 45 days) post-randomization', 'description': 'Average daily step count during the intervention period measured by Fitbit 3 activity tracker'}], 'secondaryOutcomes': [{'measure': 'Change in 5-meter timed walk as a measure of slowness', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization'}, {'measure': 'Change in exercise time as a measure of exhaustion', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Exercise time on cardiopulmonary exercise testing'}, {'measure': 'Change in respiratory exchange ratio (RER) as a measure of exhaustion', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'RER on cardiopulmonary exercise testing (exhaustion)'}, {'measure': 'Change in mini-nutritional assessment short form (MNA-SF) score', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Nutrition score as measured by MNA-SF; range 0-14; malnourished 0-7, 8-11 at-risk, and 12-14 normal nutritional status'}, {'measure': 'Change in body fat percentage', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Body fat percentage is a measure of body composition'}, {'measure': 'Change in grip strength', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization'}, {'measure': 'Change in patient reported physical activity questionnaire score', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'The physical activity questionnaire score ranges from 0 - 10,000 kilo-calories/week, with higher scores representing higher physical activity.'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scale score', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement.'}, {'measure': 'Change Patient Health Questionnaire-2 (PHQ-2) score', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Mood assessment (Range 0-6, higher score indicates higher risk of depression, \\>=3 suggestive of depression)'}, {'measure': 'Average daily active minutes', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Total average daily active minutes from Fitbit'}, {'measure': 'Average daily active minutes of moderate-high intensity activity', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Average daily active minutes of moderate-high intensity activity from Fitbit'}, {'measure': 'Average daily sedentary minutes', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Average daily sedentary minutes from Fitbit'}, {'measure': 'Change in peak respiratory oxygen uptake (VO2)', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Peak VO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline'}, {'measure': 'Change in oxygen (O2) pulse', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'O2 pulse on follow-up cardiopulmonary exercise testing, adjusted for baseline'}, {'measure': 'Change in minute ventilation/carbon dioxide production (VE/VCO2)', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'VE/VCO2 on follow-up cardiopulmonary exercise testing, adjusted for baseline'}, {'measure': 'Change in anaerobic threshold', 'timeFrame': 'Baseline and 120 days (+/- 45 days) post-randomization', 'description': 'Anaerobic threshold on follow-up cardiopulmonary exercise testing, adjusted for baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fontan', 'Single ventricle', 'Cardiac rehabilitation'], 'conditions': ['Heart Failure Congenital', 'Single-ventricle']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.\n\n1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?\n2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?", 'detailedDescription': 'REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF \\<50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 \\< 50% predicted (by FRIEND equation)\n* Age \\>= 18 years old\n\nExclusion Criteria:\n\n* Inotrope-dependence\n* Symptomatic, uncontrolled arrhythmias\n* Pregnancy\n* Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation\n* Inability to comply with the protocol\n* Recent (\\<3 months) planned Fontan pathway percutaneous or surgical intervention\n* Resting hypoxemia with baseline oxygen saturation \\<80%'}, 'identificationModule': {'nctId': 'NCT06150950', 'briefTitle': 'REHAB Fontan Failure: A Trial of Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure', 'orgStudyIdInfo': {'id': '67788'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac rehabilitation', 'description': 'For patient randomized to cardiac rehabilitation, the ACHD clinician will place the referral after they and the patient have seen the group assignment. All participants will be referred to Heart Fit for Life community-based cardiac rehabilitation program in Palo Alto, CA. Cardiac rehabilitation will be offered as an in-person, hybrid, or completely virtual program for Stanford participants and will be entirely virtual for Vanderbilt participants. Participants will attend 3 sessions per week for 12 weeks. Participants will receive weekly email reminders via the electronic medical record to encourage participation. The study protocol pertains only to referral to cardiac rehabilitation. All other aspects of the cardiac care will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.', 'interventionNames': ['Behavioral: Cardiac rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'For patients randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians. All study participants will receive a Fitbit for daily activity tracking.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Cardiac rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Cardiac rehabilitation is a multifaceted, comprehensive therapeutic intervention of personalized, supervised exercise training that is beneficial and well-studied among patients with non-ACHD heart failure and has consistently been shown to improve QOL. Unfortunately, cardiac rehabilitation has been underutilized with an overall participation \\<50% of eligible patients despite international guidelines advocating for more consistent deployment of cardiac rehabilitation. A major a barrier to cardiac rehabilitation is access, as CMS-mandates a physician be within 3 minutes of the rehabilitation facility to assure insurance reimbursement. This mandate limits isolated, outpatient cardiac rehabilitation programs, especially in rural communities.', 'armGroupLabels': ['Cardiac rehabilitation']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'For participants randomized to the usual care (no cardiac rehabilitation group), cardiac rehabilitation will not be initiated between randomization and for up to 16 weeks following randomization. The study protocol controls only referral to cardiac rehabilitation. All other aspects of the cardiac care, such as titration of guideline directed medical therapy will be at the discretion of clinicians.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'DANIEL CLARK, MD, MPH', 'role': 'CONTACT', 'email': 'danclark@stanford.edu', 'phone': '650-724-9220'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Menachem, MD', 'role': 'CONTACT', 'email': '"Jonathan Menachem" <jonathan.n.menachem@vumc.org>', 'phone': '615-322-2318'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Daniel E Clark, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Jonathan N Menachem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'Adult Congenital Heart Association', 'class': 'UNKNOWN'}, {'name': 'Julie Fletcher Memorial Fund', 'class': 'UNKNOWN'}, {'name': 'Pete Huttlinger Memorial Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Adult and Pediatric Cardiology', 'investigatorFullName': 'Daniel Clark', 'investigatorAffiliation': 'Stanford University'}}}}