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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) | Experimental |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise capacity | Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up. | Over a period of 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| New onset heart failure | Symptoms and signs of heart failure (Framingham criteria) | Over a period of 24 months |
| Change in maximal isometric grip strength | Strength (kg) measured by electronic dynamometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joel Smith, MSc | Contact | +61385321964 | joel.smith@baker.edu.au | |
| Thomas H Marwick, MD,PhD,MPH | Contact | +61385321550 | tom.marwick@baker.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Thomas H Marwick, MD,PhD,MPH | Baker Heart and Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baker Heart and Diabetes Institute | Recruiting | Melbourne | Victoria | 3004 | Australia |
Data sharing based available on application to the study PI
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomization to CC-DMP or usual care
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Outcomes assessor will receive study data based on pooled de identified dataset.
| Usual care | Other | This will be provided by participants' usual healthcare professional(s). |
|
| 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. | Over a period of 24 months |