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

NARECRUITING

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.

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.

Eligibility criteria

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

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

SCREENING

phase

Phase

    NA

trial

Study ID

NCT04983823

Intervention or treatment

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

OTHER: Usual care

Conditions

  • 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

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Baker Heart and Diabetes Institute

Select from list below to view details:

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

BHaDI

Baker Heart and Diabetes Institute

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)
    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

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime 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

      MeasureDescriptionTime 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
      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)

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