VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

NCT05724433 | Recruiting

• 1 other identifier: VICTORY-HF RCT
• Study Type: interventional
• Target: 891
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure; Randomized Controlled Trial; Digital Health; Knowledge Translation

Outcome Measures

Primary Outcomes (2)

• 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"

  30 and 90 days

• 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"

  90 and 180 days

Secondary Outcomes (4)

• GDMT use

  90 days

• Clinical Outcomes

  90 days and 180 days

• Healthcare utilization

  90 days and 180 days

• Healthcare utilization

  90 days and 180 days

Study Arms (2)

Virtual HF care

EXPERIMENTAL

Patients will receive virtual HF care to optimize medical therapies

Other: Virtual HF Care

Routine HF care

OTHER

Participants will receive routine HF care

Other: Routine HF Care

Interventions

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.

Virtual HF care

Routine HF Care OTHER

Care as determined by the treating physician

Routine HF care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator
• McMaster University: collaborator

Study Sites (9)

St. Joseph's Healthcare Hamilton

Hamilton, Onatrio, L8N 4A6, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Juravinski Hospital Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

NOT YET RECRUITING

Unity Health Toronto

Toronto, Ontario, Canada

NOT YET RECRUITING

Fattouma Bourguiba Hospital

Monastir, Tunisia

RECRUITING

Hedi Chaker Hospital

Sfax, Tunisia

RECRUITING

Sahloul Hospital

Sousse, Tunisia

RECRUITING

Military Hospital

Tunis, Tunisia

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Harriette Van Spall, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harriette GC Van Spall, MD MPH

CONTACT

(905) 521-2100; Harriette.VanSpall@phri.ca

VICTORY-HF Project office

CONTACT

victory-hf@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Cardiology, McMaster University, Population Health Research Institute

Model Details: This is an unblinded parallel multi-center Randomized Controlled Trial (RCT) of virtual HF clinics + routine care versus routine care alone in patients discharged after a hospitalization or urgent/emergency visit for HF. Randomization will be at the level of the patients and stratified by hospital site. Patients and clinicians will be unblinded, but those analyzing data will be blinded. We will adopt a pragmatic approach to this study.

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: February 13, 2023
• Study Start: January 23, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4); CA (5)