COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
This is a randomized, open-label, initiative within the Mass General Brigham healthcare system testing two remote care strategies for optimizing the prescription of guideline-directed medical therapies in patients with heart failure, regardless of left ventricular ejection fraction (LVEF).
详细描述
The primary objectives are:
- Determine if a remote, or virtual, clinic that implements a standardized, stepped-approach to guideline-directed medication optimization in patients with heart failure (across the spectrum of ejection fraction), will achieve a higher rate of guideline-directed medical therapy (GDMT) than a strategy of patient and provider education followed by remote heart failure clinic management.
- In eligible patients with LVEF<50%, determine if the sequencing of GDMT initiation (traditional vs. sodium-glucose co-transporter-2 inhibitors-first) leads to improved GDMT intensification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented diagnosis of heart failure (e.g., ICD-9 codes 428 ICD-10 codes I50 or Problem list in the electronic health record)
- •Most recent EF assessed within the past 24 months
- •Seen Mass General Brigham provider within the last 24 months
- •English or Spanish speaking
排除标准
- •LVEF<50% currently prescribed or intolerant to both ARNi and SGLT2i
- •LVEF>50% currently prescribed or intolerant to SGLT2i
- •Systolic blood pressure (SBP) <90 mmHg at last measure
- •Current severe aortic stenosis or severe aortic insufficiency
- •Known amyloid heart disease
- •Group 1 pulmonary arterial hypertension on disease-specific therapies (e.g., Ambrisentan, Bosentan, Epoprostenol, Treprostinil, Iloprost)
- •eGFR<30 mL/min/1.73m2
- •Active chemotherapy
- •Receiving end-of-life care or hospice
- •History of transplant, currently listed above status 4 or being evaluated for transplant
- •Outpatient intravenous inotrope use
- •Current use of a Ventricular Assist Device
- •Physician's discretion as inappropriate for remote management program
研究组 & 干预措施
Medication & Education-First
Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm.
干预措施: SGLT2i, beta blocker, ARNI, MRA, MTD (Drug)
Education-First
Patient will first receive curated patient education, an alert to providers, and provider education, and then after 3 months begin participation in the remote heart failure clinic.
干预措施: SGLT2i, beta blocker, ARNI, MRA, MTD (Drug)
Education-First
Patient will first receive curated patient education, an alert to providers, and provider education, and then after 3 months begin participation in the remote heart failure clinic.
干预措施: Education-First (Behavioral)
结局指标
主要结局
Primary Endpoint
时间窗: 3-months following randomization
The percent of eligible enrolled patients who achieve utilization of recommended therapy for heart failure at 3 months after randomization, which includes: • In patients with EF\<50%, utilization of 4 drug classes (ARNI/ARB/ACEI, SGLT2i, BB, and MRA), OR • In patients with EF ≥50%, utilization of SGLT2i.
次要结局
- Secondary Endpoint(6-months following randomization)
研究者
Benjamin M. Scirica, MD
Associate Professor, Harvard Medical School
Brigham and Women's Hospital