COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
- Conditions
- Heart Failure
- Interventions
- Drug: SGLT2i, beta blocker, ARNI, MRA, MTDBehavioral: Education-First
- Registration Number
- NCT05734690
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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).
- Detailed Description
The primary objectives are:
1. 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.
2. 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Medication & Education-First SGLT2i, beta blocker, ARNI, MRA, MTD 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. Education-First SGLT2i, beta blocker, ARNI, MRA, MTD 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. Education-First 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.
- Primary Outcome Measures
Name Time Method Primary Endpoint 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.
- Secondary Outcome Measures
Name Time Method Secondary Endpoint 6-months following randomization Any Intensification of guideline-directed medical therapy, which includes any initiation or titration of a GDMT medication.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States