Heart Failure
Conditions
Keywords
Heart Failure, Randomized Controlled Trial, Digital Health, Knowledge Translation
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 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.
Interventions
OTHERVirtual 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.
OTHERRoutine HF Care
Care as determined by the treating physician
Sponsors
Population Health Research Institute
Hamilton Health Sciences Corporation
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary "Hierarchical" Composite Outcome of (Part 1): | 30 and 90 days | 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. |
| Primary "Hierarchical" Composite Outcome of (Part 2): | Time Frame: 30 and 90 Days | 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). |
| Primary "Hierarchical" Composite Outcome of (Part 3): | Time Frame: 30 and 90 days. | Change in health status, as measured by the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days. |
| Co-primary "Hierarchical" Composite Outcome of: | 90 and 180 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Guideline-Directed Medical Therapy (GDMT) use | 90 days | 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. |
| Clinical Outcomes | 90 days and 180 days | 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. |
| Healthcare utilization | 90 days and 180 days | i) direct healthcare cost at 90 and 180 days. ii) number of virtual and in-person clinic visits per patient in 90 days. |
Countries
Canada, Tunisia
Contacts
CONTACTHarriette GC Van Spall, MD MPH
CONTACTVICTORY-HF Project office
PRINCIPAL_INVESTIGATORHarriette Van Spall, MD
McMaster University
Outcome results
None listed