Safety and Efficacy of Exercise in Type-B Aortic Dissection

NCT07009067 | Recruiting DMC

• 1 other identifier: KY2025-203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type B Aortic Dissection

Outcome Measures

Primary Outcomes (4)

• Adverse events during exercise

  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

  3 months

• Aortic diameter

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

  3 months

• Progression of dissection

  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

  3 months

• Endoleak

  Incidence of new endoleak after 3-month intervention.

  3 months

Study Arms (2)

Rehabilitation Group

EXPERIMENTAL

Behavioral: Exercise-based Cardiac Rehabilitation

Control Group

NO INTERVENTION

Interventions

Exercise-based Cardiac Rehabilitation BEHAVIORAL

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

Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 6, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)