Safety and Efficacy of Exercise in Type-B Aortic Dissection (SECRET-Pilot)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status

Enrolling

Conditions

Type B Aortic Dissection

Treatments

Behavioral: Exercise-based Cardiac Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT07009067

KY2025-203

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;