Type B Aortic Dissection
Conditions
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.
Interventions
BEHAVIORALExercise-based Cardiac Rehabilitation
Participated will receive 36 individualized Exercise-based Cardiac Rehabilitation after enrollment in our Cardiac Rehabilitation Center.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed