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

NCT04983823 | Recruiting

• 1 other identifier: 28/21
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart failure; COVID

Outcome Measures

Primary Outcomes (1)

• Change in exercise capacity

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

  Over a period of 24 months

Secondary Outcomes (3)

• New onset heart failure

  Over a period of 24 months

• Change in maximal isometric grip strength

  Over a period of 24 months

• Change on quality of life

  Over a period of 24 months

Study Arms (2)

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

EXPERIMENTAL

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)

Usual care

ACTIVE COMPARATOR

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

Other: Usual care

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.

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

Usual care OTHER

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

Usual care

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of COVID-19 infection
• Live within a geographically accessible area for follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Thomas H Marwick, MD,PhD,MPH

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Smith, MSc

CONTACT

+61385321964; joel.smith@baker.edu.au

Thomas H Marwick, MD,PhD,MPH

CONTACT

+61385321550; tom.marwick@baker.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will receive study data based on pooled de identified dataset.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to CC-DMP or usual care

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: July 30, 2021
• Study Start: November 18, 2021
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)