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Recruiting Not applicable

Safety and Efficacy of Exercise in Type-B Aortic Dissection

NCT07009067 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-05-06
Last updated
2025-06-06

Condition(s) studied

Type B Aortic Dissection

Investigational drug(s) / intervention(s)

Exercise-based Cardiac Rehabilitation

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

  • 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
  • Aortic diameter — 3 months
    The difference of aortic diameter before and after after 3-month intervention in mm.
  • 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
  • Endoleak — 3 months
    Incidence of new endoleak after 3-month intervention.

Trial sites (1)

FacilityCityRegionStatus
Guangdong Provincial People's Hospital Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07009067 on ClinicalTrials.gov ↗ ← All trials in China