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

Baker Heart and Diabetes Institute820 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

820

Conditions

Heart Failure

Interventions

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

A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.

Usual careOTHER

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, Australia

RECRUITING

Outcomes

Primary Outcomes

Change in exercise capacity

Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Time frame: Over a period of 24 months

Secondary Outcomes

New onset heart failure

Symptoms and signs of heart failure (Framingham criteria)

Time frame: Over a period of 24 months

Change in maximal isometric grip strength

Strength (kg) measured by electronic dynamometer

Time frame: 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.

Time frame: Over a period of 24 months

Central Contacts

Joel Smith, MSc

CONTACT

+61385321964 joel.smith@baker.edu.au

Thomas H Marwick, MD,PhD,MPH

CONTACT

+61385321550 tom.marwick@baker.edu.au

Data from ClinicalTrials.gov

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