Exercise program after endovascular repair for Type B aortic dissection

Safety and Efficacy of Cardiac Rehabilitation With Exercise in Patients With Type-B Aortic Dissection and Intervention: Pilot Study

This trial will test whether a supervised three-month exercise-based cardiac rehabilitation program is safe and helpful for people who had endovascular repair for Type B aortic dissection, intramural hematoma, or penetrating ulcer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07009067 on ClinicalTrials.gov

What this trial studies

This pilot randomized study will assign patients who underwent endovascular aortic repair for Type B aortic dissection, intramural hematoma, or penetrating ulcer to usual care or usual care plus a three-month, center-based supervised exercise cardiac rehabilitation program. Eligible participants are more than one month post-EVAR with no postoperative aortic complications on CTA and able to perform basic daily activities. The protocol focuses primarily on safety outcomes (for example endoleak, stent issues, dissection progression, and cardiac events) and will also collect functional and quality-of-life measures to signal efficacy. The goal is to determine whether structured, supervised exercise can be safely implemented and show preliminary benefit in this population.

Who should consider this trial

Good fit: Ideal candidates are adults more than one month after EVAR for Type B aortic dissection, intramural hematoma, or penetrating ulcer who have no postoperative aortic complications on CTA, can perform basic daily activities, and consent to supervised rehabilitation.

Not a fit: Patients with recent myocardial infarction, recent acute heart failure, ascending aortic aneurysm or dissection, severe valvular disease or hypertrophic obstructive cardiomyopathy, advanced renal failure, or those with postoperative complications such as endoleak or stent thrombosis are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, structured cardiac rehabilitation could safely improve physical fitness, cardiovascular health, and quality of life after endovascular repair.

How similar studies have performed: Small observational reports and rehabilitation programs in stable aortic disease suggest possible safety and fitness benefits, but randomized data specifically after EVAR for Type B dissection are scarce, making this pilot relatively novel.

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;

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)

Conditions: Type B Aortic Dissection