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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP); Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Estimated): 820
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Smith, MSc; Phone Number: +61385321964; Email: joel.smith@baker.edu.au
• Study Contact Backup: Name: Thomas H Marwick, MD,PhD,MPH; Phone Number: +61385321550; Email: tom.marwick@baker.edu.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Baker Heart and Diabetes Institute
      • Contact: Thomas Marwick; Phone Number: +61385321550; Email: tom.marwick@baker.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP); 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); 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 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

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute
• Investigators: Principal Investigator: Thomas H Marwick, MD,PhD,MPH, Baker Heart and Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): July 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; COVID
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 28/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing based available on application to the study PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No