VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 891
- 试验地点
- 9
- 主要终点
- Co-primary "Hierarchical" Composite Outcome of:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Virtual HF care
Patients will receive virtual HF care to optimize medical therapies
干预措施: Virtual HF Care (Other)
Routine HF care
Participants will receive routine HF care
干预措施: Routine HF Care (Other)
结局指标
主要结局
Co-primary "Hierarchical" Composite Outcome of:
时间窗: 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.
Primary "Hierarchical" Composite Outcome of (Part 1):
时间窗: 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):
时间窗: 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):
时间窗: 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.
次要结局
- Clinical Outcomes(90 days and 180 days)
- Healthcare utilization(90 days and 180 days)
- Guideline-Directed Medical Therapy (GDMT) use(90 days)
研究者
Harriette Van Spall
Assistant Professor of Medicine, Division of Cardiology, McMaster University, Population Health Research Institute
Population Health Research Institute