Exercise program after endovascular repair for Type B aortic dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment for Type B Aortic Dissection using Allay Aortic Stent

  This study is testing if adding the Allay® Aortic Stent to standard treatment can help people with Type B aortic dissection avoid serious complications and aortic growth.

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• Improving outcomes for patients with type B aortic dissection

  This study is testing whether a more aggressive treatment using a special procedure combined with medication can help people with type B aortic dissection do better than just using medication and regular check-ups.

  Recruiting at 55 sites Duke University · Birmingham, Alabama and 65 other locations · NCT06087029

• Evaluation of a new stent graft system for treating aortic arch and descending thoracic aorta conditions

  This study is testing a new stent graft system to see if it can safely help people with problems in their aortic arch and descending thoracic aorta, like aneurysms and dissections.

  Recruiting at 2 sites Ceric Sàrl · Brest and 3 other locations · NCT05479305

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.