COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Boehringer Ingelheim
• Treatments: Adrenergic beta-Antagonists

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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