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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to CC-DMP or usual care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)<br>Optimization of pharmacotherapy: This will be performed by a supervising clinician and will comprise treatment with angiotensin-converting enzyme inhibitor (ACEi, Ramipril) and beta blocker (Metoprolol) for cardioprotection. Exercise intervention: Individualized training program will be provided by an exercise physiologist | Other: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)<br>* A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.<br>|
| Active Comparator: Usual care<br>All medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s). | Other: Usual care<br>* This will be provided by participants' usual healthcare professional(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise capacity | Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up. | Over a period of 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New onset heart failure | Symptoms and signs of heart failure (Framingham criteria) | Over a period of 24 months | 
| Change in maximal isometric grip strength | Strength (kg) measured by electronic dynamometer | Over a period of 24 months | 
| Change on quality of life | Change in score on Health related quality of life: Assessment of quality of life 8 Dimension. Minimum value 1, Maximum value 4. Higher values indicate worse outcome. | Over a period of 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, COVID