Health TrialsbyHealthPanel

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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorBaker Heart and Diabetes Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

History of COVID-19 infection

Live within a geographically accessible area for follow-up

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.

  • Usual care

    Other intervention

    This will be provided by participants' usual healthcare professional(s).

Treatment groups

820 Participants
are divided into 2 treatment groups
Group A: Heart failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)Experimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in exercise capacity

Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up.

Time frame
Over a period of 24 months

Secondary outcomes

1

New onset heart failure

Symptoms and signs of heart failure (Framingham criteria)

Time frame
Over a period of 24 months
2

Change in maximal isometric grip strength

Strength (kg) measured by electronic dynamometer

Time frame
Over a period of 24 months
3

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.

Time frame
Over a period of 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baker Heart and Diabetes Institute

Lead sponsor

Source ClinicalTrials.gov
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