Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-03 @ 11:11 PM
Study NCT ID:
NCT07009067
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Exercise in Type-B Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events during exercise', 'timeFrame': '3 months', 'description': 'Rates of blood pressure increase ≥ 180/100 mmHg, new myocardial ischemia, and new arrhythmia during exercise; rates of dyspnea, palpitations, dizziness/syncope during exercise; and new chest pain/low back pain or worsening chest pain/low back pain'}, {'measure': 'Aortic diameter', 'timeFrame': '3 months', 'description': 'The difference of aortic diameter before and after after 3-month intervention in mm.'}, {'measure': 'Progression of dissection', 'timeFrame': '3 months', 'description': 'Increase in the number of aorta and its main branches involved in the dissection, the length of a single vessel dissection increases by more than 10 mm, or part of the dissected vessel ruptures'}, {'measure': 'Endoleak', 'timeFrame': '3 months', 'description': 'Incidence of new endoleak after 3-month intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type B Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'This is a pilot study. The goal of this clinical trial is to evaluate the safety and efficacy of exercise-based cardiac rehabilitation in patients with Type-B Aortic dissection or intramural hematoma or penetrating ulcer and received endovascular repair. The main questions it aims to answer are:\n\n• Is exercise-based cardiac rehabilitation safe among these patients? Participants will be randomly assigned to receive usual care plus exercise-based cardiac rehabilitation (guided exercise for 3 months in rehabilitation center) or usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a previous diagnosis of type B aortic dissection or intramural hematoma or penetrating ulcer, who underwent endovascular aortic repair (EVAR) or EVAR + supra-aortic shunt surgery for more than 1 month, and no related complications (such as endoleak, stent thrombosis, dissection progression, etc.) were found in the postoperative aortic CTA;\n* Able to independently carry out basic daily life activities, participants must be able to complete the baseline assessment and start the designated treatment;\n* Patients voluntarily participate in this study, sign the written informed consent, and are willing to cooperate with the follow-up;\n\nExclusion Criteria:\n\n* Acute myocardial infarction occurred 1 month ago;\n* Combined with severe aortic stenosis or regurgitation;\n* Combined with ascending aortic aneurysm or dissection;\n* Acute heart failure occurred 2 weeks ago;\n* Combined with severe hypertrophic obstructive cardiomyopathy;\n* Chronic renal failure stage 5, which is defined as glomerular filtration rate \\<15ml/(min·1.73m2) or dialysis;\n* During the screening examination, the patient's alanine aminotransferase or aspartate aminotransferase is greater than or equal to 5 times the upper limit of the normal value specified by our center;\n* Patients with any medical history that may affect compliance with the program;\n* Patients with severe language, mental or physical disabilities who are unable to participate in the program;\n* Pregnant or lactating women, or those with fertility who are unwilling/unable to take effective contraceptive measures;\n* Patients participating in other interventional clinical trials;\n* Patients with long-term high-intensity exercise habits;\n* Patients who are judged by the researchers to be unsuitable for participation in this study;"}, 'identificationModule': {'nctId': 'NCT07009067', 'acronym': 'SECRET-Pilot', 'briefTitle': 'Safety and Efficacy of Exercise in Type-B Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Safety and Efficacy of Cardiac Rehabilitation With Exercise in Patients With Type-B Aortic Dissection and Intervention: Pilot Study', 'orgStudyIdInfo': {'id': 'KY2025-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation Group', 'interventionNames': ['Behavioral: Exercise-based Cardiac Rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Exercise-based Cardiac Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Participated will receive 36 individualized Exercise-based Cardiac Rehabilitation after enrollment in our Cardiac Rehabilitation Center.', 'armGroupLabels': ['Rehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Yu, PHD', 'role': 'CONTACT', 'email': 'smileyuyuan@sina.cn', 'phone': '19866100814'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Huan Ma', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}