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RecruitingNCT04983823Updated Oct 3, 2025

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

An interventional study of Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) and Usual care in Heart Failure, sponsored by Baker Heart and Diabetes Institute. Recruiting at 1 site in Australia. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Baker Heart and Diabetes Institute · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
820
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart failure
  • COVID
03

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
820 participants (estimated)

Study arms

  • 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)

  • 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

Interventions

  • OtherHeart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)

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

  • OtherUsual care

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

05

What researchers measure

Primary outcomes

  1. 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

  1. New onset heart failure

    Symptoms and signs of heart failure (Framingham criteria)

    Time frame: Over a period of 24 months

  2. Change in maximal isometric grip strength

    Strength (kg) measured by electronic dynamometer

    Time frame: Over a period of 24 months

  3. 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

06

Study locations

1 of 1 sites recruiting
  • Baker Heart and Diabetes Institute
    Melbourne, Victoria 3004, Australia
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Data sharing based available on application to the study PI

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04983823
Lead sponsor
Baker Heart and Diabetes Institute
Responsible party
Sponsor
First posted
Jul 30, 2021
Start date
Nov 18, 2021
Primary completion
Jul 30, 2025
Completion
Dec 30, 2025 (estimated)
Last update
Oct 3, 2025

Study contacts

Joel Smith, MSc
Contact
joel.smith@baker.edu.au
+61385321964
Thomas H Marwick, MD,PhD,MPH
Contact
tom.marwick@baker.edu.au
+61385321550
Thomas H Marwick, MD,PhD,MPH
principal investigator · Baker Heart and Diabetes Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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