Assessing heart health in COVID-19 survivors over 50
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
NA · Baker Heart and Diabetes Institute · NCT04983823
This study is testing a new heart health program for COVID-19 survivors over 50 to see if it can help them improve their heart function and reduce their risk of heart failure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 820 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Baker Heart and Diabetes Institute (other) |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT04983823 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to identify and improve functional capacity in survivors of COVID-19 who are over 50 years old. Participants will be randomized to a cardio-COVID disease management plan (CC-DMP) that includes VO2 testing and imaging to detect reduced functional capacity and subclinical left ventricular dysfunction. The program will also involve clinical reviews for optimal risk factor control and exercise interventions over a 24-month period. The study seeks to demonstrate the feasibility of this approach in reducing heart failure risk among COVID-19 survivors.
Who should consider this trial
Good fit: Ideal candidates are individuals over 50 years old who have a history of COVID-19 infection.
Not a fit: Patients with significant heart valve issues, previous heart failure, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart health and reduced risk of heart failure in COVID-19 survivors.
How similar studies have performed: Other studies have shown promising results in managing cardiovascular health in COVID-19 survivors, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Melbourne, Victoria
- Baker Heart and Diabetes Institute — Melbourne, Victoria, Australia (RECRUITING)
Study contacts
- Principal investigator: Thomas H Marwick, MD,PhD,MPH — Baker Heart and Diabetes Institute
- Study coordinator: Joel Smith, MSc
- Email: joel.smith@baker.edu.au
- Phone: +61385321964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Heart failure, COVID