Clinical trial NCT07009067: Safety and Efficacy of Exercise in Type-B Aortic Dissection
Official title: Safety and Efficacy of Cardiac Rehabilitation With Exercise in Patients With Type-B Aortic Dissection and Intervention: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type B Aortic Dissection
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

• 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.


Eligibility criteria: Inclusion Criteria:

* 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;
* Able to independently carry out basic daily life activities, participants must be able to complete the baseline assessment and start the designated treatment;
* Patients voluntarily participate in this study, sign the written informed consent, and are willing to cooperate with the follow-up;

Exclusion Criteria:

* Acute myocardial infarction occurred 1 month ago;
* Combined with severe aortic stenosis or regurgitation;
* Combined with ascending aortic aneurysm or dissection;
* Acute heart failure occurred 2 weeks ago;
* Combined with severe hypertrophic obstructive cardiomyopathy;
* Chronic renal failure stage 5, which is defined as glomerular filtration rate \<15ml/(min·1.73m2) or dialysis;
* 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;
* Patients with any medical history that may affect compliance with the program;
* Patients with severe language, mental or physical disabilities who are unable to participate in the program;
* Pregnant or lactating women, or those with fertility who are unwilling/unable to take effective contraceptive measures;
* Patients participating in other interventional clinical trials;
* Patients with long-term high-intensity exercise habits;
* Patients who are judged by the researchers to be unsuitable for participation in this study;

Primary outcomes:
measure: Adverse events during exercise
timeFrame: 3 months
measure: Aortic diameter
timeFrame: 3 months
measure: Progression of dissection
timeFrame: 3 months
measure: Endoleak
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: