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Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 50 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-11-18
Primary completion: 2024-12-01
Study completion finish: 2024-12-01
Study type
SCREENING
Phase
NA
Trial ID
NCT04983823
Intervention or treatment
OTHER: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
OTHER: Usual care
Conditions
- • Heart Failure
Find a site
Closest Location:
Baker Heart and Diabetes Institute
Research sites nearby
Select from list below to view details:
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
| OTHER: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
|
ACTIVE_COMPARATOR: Usual care
| OTHER: Usual care
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 | 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 |
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