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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 820
- 试验地点
- 2
- 主要终点
- Change in exercise capacity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will receive study data based on pooled de identified dataset.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of COVID-19 infection
- •Live within a geographically accessible area for follow-up
排除标准
- •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
结局指标
主要结局
Change in exercise capacity
时间窗: Over a period of 24 months
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
次要结局
- New onset heart failure(Over a period of 24 months)
- Change in maximal isometric grip strength(Over a period of 24 months)
- Change on quality of life(Over a period of 24 months)