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.
Heart failure (HF) is a leading cause of mortality and morbidity across the world. Access to specialized HF clinics remains limited despite evidence that multidisciplinary HF care improves outcomes. VICTORY-HF is an international, multicentre, pragmatic randomized controlled trial evaluating whether a virtual HF clinic, in addition to routine care, improves implementation and clinical outcomes among patients recently discharged following hospitalization or urgent care visits for HF. Participants will be randomized to a 90-day virtual HF clinic plus routine care or routine care alone. The virtual clinic will provide structured remote follow-up, monitoring, and optimization of guideline-directed medical therapy (GDMT). The trial will evaluate the effect of the intervention on the medication optimization, patient-reported health status (KCCQ-12), all-cause mortality, HF hospitalization, and emergency department visits. The multi-centre randomized trial (CTO Project ID 4277) was preceded by a pilot randomized controlled trial (HiREB Project ID 5441) to assess the feasibility and acceptability of the intervention, refine virtual care processes, and inform the final trial protocol. Data collected during the pilot phase were limited to feasibility and process outcomes, distinct from the objectives and outcomes of the multi-center randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
891
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.
Care as determined by the treating physician
St. Joseph's Healthcare Hamilton
Hamilton, Onatrio, Canada
RECRUITINGHamilton General Hospital
Hamilton, Ontario, Canada
RECRUITINGJuravinski Hospital Cancer Centre
Hamilton, Ontario, Canada
Primary "Hierarchical" Composite Outcome of (Part 1):
Target dose of beta blockers (BB), angiotensin receptor-neprilysin inhibitor (ARNI) or angiotensin-converting enzyme inhibitor (ACEi) / angiotensin receptor blocker (ARB), mineralocorticoid receptor antagonist (MRA), and sodium-glucose cotransporter-2 inhibitor (SGLT2i) at 90 days.
Time frame: 30 and 90 days
Primary "Hierarchical" Composite Outcome of (Part 2):
2\. Guideline-directed medical therapy (GDMT) intensification at 30 days, defined as: 1. initiation or up-titration of a beta blocker; 2. switch from another beta blocker to carvedilol, bisoprolol, or extended-release metoprolol succinate; 3. initiation or up-titration of an angiotensin-converting enzyme inhibitor (ACE inhibitor), angiotensin receptor blocker (ARB), or angiotensin receptor-neprilysin inhibitor (ARNI); 4. switch from an angiotensin-converting enzyme inhibitor (ACE inhibitor) or angiotensin receptor blocker (ARB) to an angiotensin receptor-neprilysin inhibitor (ARNI); 5. initiation or up-titration of a mineralocorticoid receptor antagonist (MRA); or 6. initiation of a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor).
Time frame: Time Frame: 30 and 90 Days
Primary "Hierarchical" Composite Outcome of (Part 3):
Change in health status, as measured by the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days.
Time frame: Time Frame: 30 and 90 days.
Co-primary "Hierarchical" Composite Outcome of:
1. All-cause death at 180 days. 2. Heart failure (HF) hospitalization at 180 days. 3. All-cause emergency department (ED) visit at 180 days. 4. Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days. These Co-Primary Hierarchical Composite Outcomes were the original Primary Outcomes for this trial. The Primary "Original" Outcome listed below applies only to the single-center pilot phase of the trial.
Time frame: 90 and 180 days
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Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
NOT_YET_RECRUITINGUnity Health Toronto
Toronto, Ontario, Canada
RECRUITINGFattouma Bourguiba Hospital
Monastir, Tunisia
RECRUITINGHedi Chaker Hospital
Sfax, Tunisia
RECRUITINGSahloul Hospital
Sousse, Tunisia
RECRUITINGMilitary Hospital
Tunis, Tunisia
RECRUITINGGuideline-Directed Medical Therapy (GDMT) use
Achievement of at least 50% of the target doses of beta blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, sodium-glucose cotransporter-2 inhibitors at 90 days.
Time frame: 90 days
Clinical Outcomes
i) Time to composite all-cause death, heart failure hospitalization, or all-cause emergency department visit at 180 days ii) Components of composite endpoint * Time to all-cause death * Time to heart failure hospitalization * Time to all-cause emergency department visit iii) Change in health status (Kansas City Cardiomyopathy Questionnaire-12 summary score) at 90 days The Secondary "Original" Outcomes listed below apply only to the single-center pilot phase.
Time frame: 90 days and 180 days
Healthcare utilization
i) direct healthcare cost at 90 and 180 days. ii) number of virtual and in-person clinic visits per patient in 90 days.
Time frame: 90 days and 180 days