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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Baker Heart and Diabetes Institute
- Enrollment
- 820
- Locations
- 1
- Primary Endpoint
- Change in exercise capacity
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of COVID-19 infection
- •Live within a geographically accessible area for follow-up
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in exercise capacity
Time Frame: Over a period of 24 months
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
Secondary Outcomes
- 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)