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
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.
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.
Exclusion Criteria:
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)
All medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s).
Other: Usual care
A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
This will be provided by participants' usual healthcare professional(s).
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
New onset heart failure
Symptoms and signs of heart failure (Framingham criteria)
Time frame: Over a period of 24 months
Change in maximal isometric grip strength
Strength (kg) measured by electronic dynamometer
Time frame: 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.
Time frame: Over a period of 24 months
Plan to share: No — Data sharing based available on application to the study PI
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Baker Heart and Diabetes Institute