Safety and Efficacy of Exercise in Type-B Aortic Dissection

Not Applicable

Recruiting

• Conditions: Type B Aortic Dissection

• Registration Number: NCT07009067
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-28
• Status Verified: 2025-05
• Study Start: 2025-05-06
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endoleak	3 months	Incidence of new endoleak after 3-month intervention.
Aortic diameter	3 months	The difference of aortic diameter before and after after 3-month intervention in mm.
Adverse events during exercise	3 months	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
Progression of dissection	3 months	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

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China