Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)

Официальное название

Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE): A Randomised Controlled Trial of the Role of Optimal Cardioprotection Strategies to Prevent Heart Failure

Обзор

This is a prospective study in which a process of identifying and improving a reduction of functional capacity in COVID-19 survivors \>50 years old. The overall goal of this study to identify the feasibility and value of risk-guided medical therapy and exercise intervention in COVID-19 survivors.

Подробное описание

Participants enrolled in this study will be randomized to a cardio-COVID disease management plan (CC-DMP) that involves the use of VO2 testing and surveillance imaging to detect reduced functional capacity and subclinical left ventricular dysfunction (LVD), clinical review to ensure optimal risk factor control and cardio-protection and exercise intervention. The program will be delivered over a period of 24 months.

The outcome from this study will show that subclinical LVD is common among COVID-19 survivors, and a CC-DMP is feasible in reducing HF risk factors in this sub group of survivors.

Вмешательства

• Другое Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
  A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
• Другое Usual care
  This will be provided by participants' usual healthcare professional(s).

Первичные конечные точки

• Change in exercise capacity [Срок оценки: Over a period of 24 months]

Вторичные конечные точки (3)

• New onset heart failure [Срок оценки: Over a period of 24 months]
• Change in maximal isometric grip strength [Срок оценки: Over a period of 24 months]
• Change on quality of life [Срок оценки: Over a period of 24 months]

Критерии участия

Критерии включения

• History of COVID-19 infection
• Live within a geographically accessible area for follow-up

Критерии исключения

• Valvular stenosis or regurgitation of >moderate severity
• History of previous heart failure (baseline New York Heart Association (NYHA) classification >2)
• Inability to acquire interpretable images (identified from baseline echo)
• Contraindications to beta blockers or angiotensin-converting enzyme inhibitors
• Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
• Already taking both angiotensin converting enzyme inhibitors/ angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both.
• Mobility impairment that would impact participants' ability to perform exercise
• Unable to provide written informed consent to participate in this study

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Австралия · 1 центр

• Baker Heart and Diabetes Institute — Melbourne

Идентификаторы

NCT: NCT04983823 · 28/21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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