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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Virtual HF Care; Other: Routine HF Care

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 891
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harriette GC Van Spall, MD MPH; Phone Number: 40601 (905) 521-2100; Email: Harriette.VanSpall@phri.ca
• Study Contact Backup: Name: VICTORY-HF Project office; Email: victory-hf@phri.ca

Study Locations

• Canada
  • Onatrio
    • Hamilton, Onatrio, Canada, L8N 4A6
      • Recruiting
      • St. Joseph's Healthcare Hamilton
      • Contact: Katie Connolly, Dr
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton General Hospital
      • Contact: Harriette Van Spall, Dr
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Hospital Cancer Centre
      • Contact: Serena Gundy, Dr.
    • Thunder Bay, Ontario, Canada
      • Not yet recruiting
      • Thunder Bay Regional Health Sciences Centre
      • Contact: Vahid Akbari; Phone Number: 807-684-7580; Email: Vahid.Akbari@tbh.net
    • Toronto, Ontario, Canada
      • Not yet recruiting
      • Unity Health Toronto
      • Contact: Peter Mitoff; Phone Number: 416-766-1162; Email: Peter.Mitoff@unityhealth.to
• Tunisia
  • Monastir, Tunisia
    • Recruiting
    • Fattouma Bourguiba Hospital
    • Contact: Semir Nouira; Phone Number: +21673106000; Email: semir.nouira@rns.tn
  • Sfax, Tunisia
    • Recruiting
    • Hédi Chaker Hospital
    • Contact: Leila Abid; Phone Number: +21674244511; Email: leilaabidt@yahoo.fr
  • Sousse, Tunisia
    • Recruiting
    • Sahloul Hospital
    • Contact: Riadh Boukef; Phone Number: +21673369411; Email: riadboukef@gmail.com
  • Tunis, Tunisia
    • Recruiting
    • Military Hospital
    • Contact: Wafa Fehri; Phone Number: +21671391133; Email: wafafehri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adult patients ≥ 18 years old who:

1. Are being discharged after hospitalization or urgent visit for HF as

   1. a primary diagnosis or
   2. 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.
2. Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.
3. Have NT-proBNP of > 900 pg/ml during hospital admission or within 7 days after discharge from the ED
4. Have a mailing address for patient or caregiver
5. Provide verbal consent

Exclusion Criteria:

1. Died or left hospital before medically advised hospital discharge
2. Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)
3. Unable to engage with digital health technology or follow up
4. Severe valve disease
5. Recipient of or on waiting list for LVAD or cardiac transplant
6. Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy
7. 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
8. Severe kidney disease (persistent eGFR < 30 mL/min/1.73m2)
9. Active malignancy
10. Receiving palliative care or expected life expectancy < 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual HF care; Patients will receive virtual HF care to optimize medical therapies	Other: Virtual HF Care; 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.
Other: Routine HF care; Participants will receive routine HF care	Other: Routine HF Care; Care as determined by the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary "Hierarchical" Composite Outcome of:	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"	30 and 90 days
Co-primary "Hierarchical" Composite Outcome of:	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"	90 and 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GDMT use	Achievement of at least 50% of the target doses of BB, ACEi/ARB or ARNI, MRA, SGLT2i at 90 days.	90 days
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	90 days and 180 days
Healthcare utilization	i) direct healthcare cost at 90 and 180 days	90 days and 180 days
Healthcare utilization	ii) number of virtual and in-person clinic visits per patient in 90 days.	90 days and 180 days

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: McMaster University; Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Harriette Van Spall, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 31, 2019
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Randomized Controlled Trial; Digital Health; Knowledge Translation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: VICTORY-HF RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No