Safety and Efficacy of Exercise in Type-B Aortic Dissection

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Adverse events during exercise [Срок оценки: 3 months]
• Aortic diameter [Срок оценки: 3 months]
• Progression of dissection [Срок оценки: 3 months]
• Endoleak [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07009067 · KY2025-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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