Safety and Efficacy of Exercise in Type-B Aortic Dissection

NCT ID: NCT07009067

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-06
• Study Completion Date: 2028-12-31

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.

Conditions

Type B Aortic Dissection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rehabilitation Group

Group Type: EXPERIMENTAL

Exercise-based Cardiac Rehabilitation

Intervention Type: BEHAVIORAL

Participated will receive 36 individualized Exercise-based Cardiac Rehabilitation after enrollment in our Cardiac Rehabilitation Center.

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise-based Cardiac Rehabilitation

Participated will receive 36 individualized Exercise-based Cardiac Rehabilitation after enrollment in our Cardiac Rehabilitation Center.

Intervention Type: BEHAVIORAL

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huan Ma

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yuan Yu, PHD

Role: primary

smileyuyuan@sina.cn

19866100814

Other Identifiers

KY2025-203

Identifier Type: -

Identifier Source: org_study_id