Health TrialsbyHealthPanel

Safety and Efficacy of Exercise in Type-B Aortic Dissection

ConditionType B Aortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise-based Cardiac Rehabilitation

    Behavioral

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Rehabilitation GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 months
2

Aortic diameter

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

Time frame
3 months
3

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

Time frame
3 months
4

Endoleak

Incidence of new endoleak after 3-month intervention.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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