VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Routine HF Care; Other: Virtual HF Care

• Registration Number: NCT05724433
• Lead Sponsor: Population Health Research Institute

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.

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 Timeline

• Study First Submitted: 2019-08-31
• Study Start: 2023-01-23
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 891

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine HF care	Routine HF Care	Participants will receive routine HF care
Virtual HF care	Virtual HF Care	Patients will receive virtual HF care to optimize medical therapies

Primary Outcome Measures

Name	Time	Method
Primary "Hierarchical" Composite Outcome of:	30 and 90 days	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"
Co-primary "Hierarchical" Composite Outcome of:	90 and 180 days	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"

Secondary Outcome Measures

Name	Time	Method
GDMT use	90 days	Achievement of at least 50% of the target doses of BB, ACEi/ARB or ARNI, MRA, SGLT2i at 90 days.
Clinical Outcomes	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
Healthcare utilization	90 days and 180 days	ii) number of virtual and in-person clinic visits per patient in 90 days.

Trial Locations

Locations (9)

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada

Unity Health Toronto; 🇨🇦 Toronto, Ontario, Canada

Fattouma Bourguiba Hospital; 🇹🇳 Monastir, Tunisia

Hedi Chaker Hospital; 🇹🇳 Sfax, Tunisia

Sahloul Hospital; 🇹🇳 Sousse, Tunisia

Military Hospital; 🇹🇳 Tunis, Tunisia

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Onatrio, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Juravinski Hospital Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada