VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

Official title

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

Overview

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

• 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
  Care as determined by the treating physician

Primary outcome measures

• Primary "Hierarchical" Composite Outcome of (Part 1): [Time frame: 30 and 90 days]
• Primary "Hierarchical" Composite Outcome of (Part 2): [Time frame: Time Frame: 30 and 90 Days]
• Primary "Hierarchical" Composite Outcome of (Part 3): [Time frame: Time Frame: 30 and 90 days.]
• Co-primary "Hierarchical" Composite Outcome of: [Time frame: 90 and 180 days]

Secondary outcome measures (3)

• Guideline-Directed Medical Therapy (GDMT) use [Time frame: 90 days]
• Clinical Outcomes [Time frame: 90 days and 180 days]
• Healthcare utilization [Time frame: 90 days and 180 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Canada · 5 centers

• St. Joseph's Healthcare Hamilton — Hamilton
• Hamilton General Hospital — Hamilton
• Juravinski Hospital Cancer Centre — Hamilton
• Thunder Bay Regional Health Sciences Centre — Thunder Bay
• Unity Health Toronto — Toronto

Tunisia · 4 centers

• Fattouma Bourguiba Hospital — Monastir
• Hedi Chaker Hospital — Sfax
• Sahloul Hospital — Sousse
• Military Hospital — Tunis

Identifiers

NCT: NCT05724433 · VICTORY-HF RCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗