search
Back to results

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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
Usual care
Sponsored by
Baker Heart and Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Heart Failure focused on measuring Heart failure, COVID

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baker Heart and Diabetes InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)

Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in exercise capacity
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Secondary Outcome Measures

New onset heart failure
Symptoms and signs of heart failure (Framingham criteria)
Change in maximal isometric grip strength
Strength (kg) measured by electronic dynamometer
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.

Full Information

First Posted
July 29, 2021
Last Updated
February 1, 2023
Sponsor
Baker Heart and Diabetes Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04983823
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baker Heart and Diabetes Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, COVID

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to CC-DMP or usual care
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will receive study data based on pooled de identified dataset.
Allocation
Randomized
Enrollment
820 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
All medical management for participants allocated to this group will be at the discretion of their usual care healthcare professional(s).
Intervention Type
Other
Intervention Name(s)
Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)
Intervention Description
A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
This will be provided by participants' usual healthcare professional(s).
Primary Outcome Measure Information:
Title
Change in exercise capacity
Description
Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.
Time Frame
Over a period of 24 months
Secondary Outcome Measure Information:
Title
New onset heart failure
Description
Symptoms and signs of heart failure (Framingham criteria)
Time Frame
Over a period of 24 months
Title
Change in maximal isometric grip strength
Description
Strength (kg) measured by electronic dynamometer
Time Frame
Over a period of 24 months
Title
Change on quality of life
Description
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.
Time Frame
Over a period of 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: History of COVID-19 infection Live within a geographically accessible area for follow-up Exclusion Criteria: Valvular stenosis or regurgitation of >moderate severity History of previous heart failure (baseline New York Heart Association (NYHA) classification >2) Inability to acquire interpretable images (identified from baseline echo) Contraindications to beta blockers or angiotensin-converting enzyme inhibitors 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 Already taking both angiotensin converting enzyme inhibitors/ angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both. Mobility impairment that would impact participants' ability to perform exercise Unable to provide written informed consent to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Smith, MSc
Phone
+61385321964
Email
joel.smith@baker.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas H Marwick, MD,PhD,MPH
Phone
+61385321550
Email
tom.marwick@baker.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H Marwick, MD,PhD,MPH
Organizational Affiliation
Baker Heart and Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baker Heart and Diabetes Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Marwick
Phone
+61385321550
Email
tom.marwick@baker.edu.au

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing based available on application to the study PI

Learn more about this trial

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

We'll reach out to this number within 24 hrs