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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04983823
• Other study ID #: 28/21
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Baker Heart and Diabetes Institute
• Contact: Joel Smith, MSc
• Phone: +61385321964
• Email: joel.smith[@]baker.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 820
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Virus Diseases

Intervention

Other:
• 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.
• Usual care
This will be provided by participants' usual healthcare professional(s).

Locations

Country	Name	City	State
Australia	Baker Heart and Diabetes Institute	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise capacity	Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.	Over a period of 24 months
Secondary	New onset heart failure	Symptoms and signs of heart failure (Framingham criteria)	Over a period of 24 months
Secondary	Change in maximal isometric grip strength	Strength (kg) measured by electronic dynamometer	Over a period of 24 months
Secondary	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