Heart FailureNCT04983823
Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)
A study testing Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) in people with Heart Failure, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Nov 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of COVID-19 infection
- Live within a geographically accessible area for follow-up
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
Thomas Marwick, +61385321550, tom.marwick@baker.edu.au
About this study
Official title: 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.
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.
- Conditions
- Heart Failure
- Being tested
- Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP), Usual care
- Keywords
- Heart failure, COVID
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise capacity
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
Measured: Over a period of 24 months
Secondary outcomes (3)
New onset heart failure
Symptoms and signs of heart failure (Framingham criteria)
Measured: Over a period of 24 months
Change in maximal isometric grip strength
Strength (kg) measured by electronic dynamometer
Measured: 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.
Measured: Over a period of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start18 Nov 2021
- Primary completion30 Jul 2025
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to CC-DMP or usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas H Marwick, MD,PhD,MPH, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983823
- Sponsor's protocol ID
- 28/21
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing based available on application to the study PI
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04983823
- Acronym / sponsor ID
- 28/21
- Conditions
- Heart Failure
- Keywords
- Heart failure, COVID
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization to CC-DMP or usual care
| Arm | Type | Receives |
|---|---|---|
| Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) | Experimental | Other: 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 |
| Usual care | Active comparator | Other: Usual careAll medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of COVID-19 infection
- Live within a geographically accessible area for follow-up
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) |
| Usual careThis will be provided by participants' usual healthcare professional(s). | Other | Usual care |
Primary outcome
Change in exercise capacity
Time frame: Over a period of 24 months
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
3 secondary outcomes
New onset heart failure
Time frame: Over a period of 24 months
Change in maximal isometric grip strength
Time frame: Over a period of 24 months
Change on quality of life
Time frame: Over a period of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. Data sharing based available on application to the study PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas H Marwick, MD,PhD,MPH principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) in people with Heart Failure, run by Baker Heart and Diabetes Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Smith, MSc (+61385321964, joel.smith@baker.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise capacity (time frame: Over a period of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.