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NCT Number: NCT07009067

Safety and Efficacy of Exercise in Type-B Aortic Dissection

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Yuan Yu, PHD

CONTACT

[email protected]

19866100814

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Exercise-based Cardiac Rehabilitation

Behavioral

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

Primary outcomes

  1. Adverse events during exercise

    Time frame: 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

  2. Aortic diameter

    Time frame: 3 months

    The difference of aortic diameter before and after after 3-month intervention in mm.

  3. Progression of dissection

    Time frame: 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

  4. Endoleak

    Time frame: 3 months

    Incidence of new endoleak after 3-month intervention.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Acronym: SECRET-Pilot

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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