Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05818605
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2023-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, blinded'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Myocardial Perfussion', 'timeFrame': 'Baseline and 24 Weeks', 'description': 'Change in Regional myocardial perfusion (ml/min/gm) by PET'}, {'measure': 'Change in Coronary Flow reserve', 'timeFrame': 'Baseline and 24 Weeks', 'description': 'Change in coronary flow reserve (ratio, no unit) by PET'}], 'primaryOutcomes': [{'measure': 'Change in V O2 max', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET'}, {'measure': 'Change in peak VO2 %', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Change in peak VO2 % predicted (%) by CPET'}], 'secondaryOutcomes': [{'measure': 'Change in Myocardial Systolic Strain', 'timeFrame': 'Baseline and 24 Weeks', 'description': 'Change in Myocardial systolic strain (%) by echocardiography'}, {'measure': 'Change in Myocardial Work', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Change Myocardial work (mmHg%) by echocardiography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': "The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.\n2. Left ventricular outflow tract gradient \\<30 mmHg at rest and with provocation.\n3. Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.\n4. Access to exercise equipment at home or at a fitness center.\n5. Ability to complete study related testing including online surveys and smart phone use\n6. Ability to perform 24 weeks of exercise training\n\nExclusion Criteria:\n\n1. History of exercise-induced syncope or ventricular arrhythmias\n2. LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after\n3. History of septal reduction therapy - surgery or ablation\n4. History of ICD placement in the previous 3 months\n5. History of hypotensive response with exercise testing (\\>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure \\>20 mm Hg)\n6. Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms\n7. Left ventricular ejection fraction less than 50% by echocardiography\n8. Life expectancy less than 12 months\n9. Pregnant or planned pregnancy\n10. Inability to exercise owing to any medical or other limitations\n11. Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group."}, 'identificationModule': {'nctId': 'NCT05818605', 'acronym': 'EXCITE-HCM', 'briefTitle': 'Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The EXerCise traIning To rEcovery in HCM Trial', 'orgStudyIdInfo': {'id': 'R01HL157238', 'link': 'https://reporter.nih.gov/quickSearch/R01HL157238', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HL157238', 'link': 'https://reporter.nih.gov/quickSearch/R01HL157238', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate Intensity Exercise arm', 'description': 'All patients randomized to the exercise training group will undergo a single supervised in-hospital exercise session that includes an exercise consultation with a certified exercise physiologist. Following that they will exercise at-home with video supervision 3 times a week for a period of 24 weeks.', 'interventionNames': ['Behavioral: Moderate Intensity Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Usual physical activity arm', 'description': 'Patients randomized to the usual-activity group will be instructed to continue their current activity without initiating or intensifying any existing exercise regimens for the duration of the study'}], 'interventions': [{'name': 'Moderate Intensity Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Subjects randomized to the EXER arm will undergo 24 weeks of Moderate Intensity Exercise Training (MIET). Patients will be signed up for 60-minute exercise sessions, 3 times a week', 'armGroupLabels': ['Moderate Intensity Exercise arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cynthia Partida-Higuera, CCRP', 'role': 'CONTACT', 'email': 'Cynthia.Partida-Higuera@ucsf.edu', 'phone': '415-514-1125'}, {'name': 'Theodore P Abraham, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Cynthia Partida-Higuera, CCRP', 'role': 'CONTACT', 'email': 'Cynthia.Partida-Higuera@ucsf.edu', 'phone': '415-514-1125'}], 'overallOfficials': [{'name': 'Theodore P Abraham, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}