Health TrialsbyHealthPanel

VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

About this trial

The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are being discharged after hospitalization or urgent visit for HF as

a primary diagnosis or

significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.

Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.

Disqualifiers

Died or left hospital before medically advised hospital discharge

Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)

Unable to engage with digital health technology or follow up

Severe valve disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual HF Care

    Other intervention

    Patients will receive virtual visits for 3 months following hospitalization / emergency department (ED) visit for HF. Physiologic measures will be monitored remotely and therapies will be optimized.

  • Routine HF Care

    Other intervention

    Care as determined by the treating physician

Treatment groups

891 Participants
are divided into 2 treatment groups
Group A: Virtual HF careExperimental treatment 1 intervention
Group B: Routine HF careOther 1 intervention

Trial outcomes

Primary outcomes

1

Primary "Hierarchical" Composite Outcome of:

1. Target dose of BB, ARNI or ACEi/ARB, MRA, and SGLT2i at 90 days 2. GDMT intensification at 30 days, defined as (a) initiation or up-titration of beta-blocker; (b) switch from another beta blocker to carvedilol, bisoprolol, or extended-release metoprolol; (c) initiation or up-titration of ACEi/ARB or ARNI; (d) switch from ACEi/ARB to ARNI; (e) initiation or up-titration of MRA; or (f) initiation of SGLT2i 3. Change in health status, as measured by the KCCQ-12 summary score at 90 days PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES"

Time frame
30 and 90 days
2

Co-primary "Hierarchical" Composite Outcome of:

1. All cause death at 180 days 2. HF hospitalization at 180 days 3. All-cause ED visit at 180 days 4. Change in KCCQ-12 summary score at 90 days PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES"

Time frame
90 and 180 days

Secondary outcomes

1

GDMT use

Achievement of at least 50% of the target doses of BB, ACEi/ARB or ARNI, MRA, SGLT2i at 90 days.

Time frame
90 days
2

Clinical Outcomes

i) Time to composite all-cause death, HF hospitalization, or all-cause ED visit at 180 days ii) Components of composite endpoint * Time to all-cause death * Time to HF hospitalization * Time to all-cause ED visit iii) Change in health status (KCCQ-12 summary score) at 90 days

Time frame
90 days and 180 days
3

Healthcare utilization

i) direct healthcare cost at 90 and 180 days

Time frame
90 days and 180 days
4

Healthcare utilization

ii) number of virtual and in-person clinic visits per patient in 90 days.

Time frame
90 days and 180 days

Other outcomes

Sponsors and contacts

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

Population Health Research Institute

Lead sponsor

Hamilton Health Sciences Corporation

Collaborator

McMaster University

Collaborator

Source ClinicalTrials.gov
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