Heart Failure
Conditions
Keywords
Heart failure, COVID
Brief 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.
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.
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).
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will receive study data based on pooled de identified dataset.
Intervention model description
Randomization to CC-DMP or usual care
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity | Over a period of 24 months | Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New onset heart failure | Over a period of 24 months | Symptoms and signs of heart failure (Framingham criteria) |
| Change in maximal isometric grip strength | Over a period of 24 months | Strength (kg) measured by electronic dynamometer |
| Change on quality of life | Over a period of 24 months | 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. |
Countries
Australia
Contacts
Primary ContactJoel Smith, MSc
Backup ContactThomas H Marwick, MD,PhD,MPH
Outcome results
None listed