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NCT Number: NCT05724433

VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton, Hamilton, Onatrio, Canada

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About this study

Heart failure (HF) is a leading cause of death, hospitalization, and healthcare system expenditure in Canada. While care in HF clinics - multidisciplinary clinics that focus on optimal management of HF - improves health outcomes in HF, there are disparities in access to such care across our province. To respond to the needs of patients and the health care system, the investigators propose to develop and implement a virtual model of care that will enable Canadians with HF to receive outpatient HF care and medical optimization remotely. The investigators hypothesize that relative to routine care alone, virtual HF clinics will improve a composite of implementation and clinical outcomes.

A pilot phase was conducted to assess the acceptability and feasibility of the intervention, assess change in health status, refine the virtual delivery process and healthcare processes, and use these to finalize protocols and guide the larger clinical trial. Data collection during the pilot phase focused on the process outcomes approved by HiREB (ID 5441).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients ≥ 18 years old who:

  • 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.
  • Have NT-proBNP of > 900 pg/ml during hospital admission or within 7 days after discharge from the ED
  • Have a mailing address for patient or caregiver
  • Provide verbal consent

Exclusion criteria

  • 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
  • Recipient of or on waiting list for LVAD or cardiac transplant
  • Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy
  • Severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (FEV1) < 1 litre, severe pulmonary hypertension with RVSP > 60 mm Hg, or on home oxygen
  • Severe kidney disease (persistent eGFR < 30 mL/min/1.73m2)
  • Active malignancy
  • Receiving palliative care or expected life expectancy < 6 months

Treatment and study plan

Virtual HF Care

Other

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

Care as determined by the treating physician

Primary outcomes

  1. Primary "Hierarchical" Composite Outcome of:

    Time frame: 30 and 90 days

    • Target dose of BB, ARNI or ACEi/ARB, MRA, and SGLT2i at 90 days
    • 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
    • Change in health status, as measured by the KCCQ-12 summary score at 90 days

    PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES"

  2. Co-primary "Hierarchical" Composite Outcome of:

    Time frame: 90 and 180 days

    • All cause death at 180 days
    • HF hospitalization at 180 days
    • All-cause ED visit at 180 days
    • Change in KCCQ-12 summary score at 90 days

    PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES"

Secondary outcomes

  1. GDMT use

    Time frame: 90 days

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

  2. Clinical Outcomes

    Time frame: 90 days and 180 days

    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
  3. Healthcare utilization

    Time frame: 90 days and 180 days

    i) direct healthcare cost at 90 and 180 days

  4. Healthcare utilization

    Time frame: 90 days and 180 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Harriette GC Van Spall, MD MPH

CONTACT

[email protected]

(905) 521-2100 ext. 40601

VICTORY-HF Project office

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • McMaster University

Registry information

Official study title

VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT

Acronym: VICTORY-HF

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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