Share

Save

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

RECRUITING

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.

info
Simpliy with AI

Study details:

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.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
  • info
    Simplify with AI

    Eligibility

    Age eligible for study : 50 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-11-18

    Primary completion: 2024-12-01

    Study completion finish: 2024-12-01

    study type

    Study type

    SCREENING

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04983823

    Intervention or treatment

    OTHER: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)

    OTHER: Usual care

    Conditions

    • Heart Failure
    Image related to Heart Failure
    • Condition: Heart Failure

    • OTHER: Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP) and other drugs

    • Melbourne, Victoria, Australia

    • Sponsor: Baker Heart and Diabetes Institute

    Find a site

    Closest Location:

    Baker Heart and Diabetes Institute

    Research sites nearby

    Select from list below to view details:

    • Baker Heart and Diabetes Institute

      Melbourne, Victoria, Australia

    Loading...

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: 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
    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.
    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: Usual care
    • This will be provided by participants' usual healthcare professional(s).

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in exercise capacityCardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.Over a period of 24 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    New onset heart failureSymptoms and signs of heart failure (Framingham criteria)Over a period of 24 months
    Change in maximal isometric grip strengthStrength (kg) measured by electronic dynamometerOver a period of 24 months
    Change on quality of lifeChange 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

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

    Clinical Trials Gov: Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)

    Other trails to consider

    Top searched conditions