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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04983823




Registration number
NCT04983823
Ethics application status
Date submitted
29/07/2021
Date registered
30/07/2021
Date last updated
2/02/2023

Titles & IDs
Public title
Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)
Scientific 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
Secondary ID [1] 0 0
28/21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
Other interventions - Usual care

Experimental: Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) - 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.
Exercise intervention: Individualized training program will be provided by an exercise physiologist

Active Comparator: Usual care - All medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s).


Other interventions: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.

Other interventions: Usual care
This will be provided by participants' usual healthcare professional(s).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in exercise capacity
Timepoint [1] 0 0
Over a period of 24 months
Secondary outcome [1] 0 0
New onset heart failure
Timepoint [1] 0 0
Over a period of 24 months
Secondary outcome [2] 0 0
Change in maximal isometric grip strength
Timepoint [2] 0 0
Over a period of 24 months
Secondary outcome [3] 0 0
Change on quality of life
Timepoint [3] 0 0
Over a period of 24 months

Eligibility
Key inclusion criteria
1. History of COVID-19 infection

2. Live within a geographically accessible area for follow-up
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Screening
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
820
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04983823
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas H Marwick, MD,PhD,MPH
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joel Smith, MSc
Address 0 0
Country 0 0
Phone 0 0
+61385321964
Fax 0 0
Email 0 0
joel.smith@baker.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04983823