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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 50 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-11-18

Primary completion: 2024-12-01

Study completion finish: 2024-12-01

Study type

SCREENING

Phase

Trial ID

NCT04983823

Intervention or treatment

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

OTHER: Usual care

Conditions

• Heart Failure

Condition: Heart Failure
OTHER: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) and other drugs
Melbourne, Victoria, Australia
Sponsor: Baker Heart and Diabetes Institute

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Find a site

Closest Location:

Baker Heart and Diabetes Institute

Research sites nearby

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Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) 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	OTHER: 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.
ACTIVE_COMPARATOR: Usual care All medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s).	OTHER: Usual care This will be provided by participants' usual healthcare professional(s).

Participant Group/Arm

Intervention/Treatment

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

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

OTHER: 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.

ACTIVE_COMPARATOR: Usual care

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

OTHER: Usual care

This will be provided by participants' usual healthcare professional(s).

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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References

Clinical Trials Gov: Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)