Clinical trial NCT04983823: Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)
Official title: Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE): A Randomised Controlled Trial of the Role of Optimal Cardioprotection Strategies to Prevent Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
COVID
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 820
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to CC-DMP or usual care
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in exercise capacity
timeFrame: Over a period of 24 months
Secondary outcomes:
measure: New onset heart failure
timeFrame: Over a period of 24 months
measure: Change in maximal isometric grip strength
timeFrame: Over a period of 24 months
measure: Change on quality of life
timeFrame: Over a period of 24 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Thomas H Marwick, MD,PhD,MPH
role: PRINCIPAL_INVESTIGATOR
References: