Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Usual care; Other: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)

• Registration Number: NCT04983823
• Lead Sponsor: Baker Heart and Diabetes Institute

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.

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-07-30
• Study Start: 2021-11-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 820

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	All medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s).
Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)	Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)	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

Primary Outcome Measures

Name	Time	Method
Change in exercise capacity	Over a period of 24 months	Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Baker Heart and Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia