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

Baker Heart and Diabetes Institute

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP); Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04983823

28/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 820 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. History of COVID-19 infection
2. Live within a geographically accessible area for follow-up

Exclusion criteria

1. Valvular stenosis or regurgitation of >moderate severity
2. History of previous heart failure (baseline New York Heart Association (NYHA) classification >2)
3. Inability to acquire interpretable images (identified from baseline echo)
4. Contraindications to beta blockers or angiotensin-converting enzyme inhibitors
5. 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
6. Already taking both angiotensin converting enzyme inhibitors/ angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both.
7. Mobility impairment that would impact participants' ability to perform exercise
8. Unable to provide written informed consent to participate in this study

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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820 participants in 2 patient groups

Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)

Experimental group

Description:

1. 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. 2. Exercise intervention: Individualized training program will be provided by an exercise physiologist

Treatment:

Other: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)

Usual care

Active Comparator group

Description:

All medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s).

Treatment:

Other: Usual care