RecruitingNot ApplicableNCT07009067

Safety and Efficacy of Exercise in Type-B Aortic Dissection

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


Sponsor

Guangdong Provincial People's Hospital

Enrollment

20 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria13

  • 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;

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Interventions

BEHAVIORALExercise-based Cardiac Rehabilitation

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


Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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NCT07009067


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