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

NCT ID: NCT05734690

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2025-06-09

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SGLT2i, beta blocker, ARNI, MRA, MTD

Intervention Type: DRUG

Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.

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.

Group Type: ACTIVE_COMPARATOR

SGLT2i, beta blocker, ARNI, MRA, MTD

Intervention Type: DRUG

Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.

Education-First

Intervention Type: BEHAVIORAL

For the first 3-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 3 months, be invited to participate in the remote heart failure clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for heart failure therapy. Provider education will also consist of the program's medical algorithm and a summary sheet on indications, outcomes, prescribing, and monitoring information

Interventions

SGLT2i, beta blocker, ARNI, MRA, MTD

Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.

Intervention Type: DRUG

Education-First

For the first 3-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 3 months, be invited to participate in the remote heart failure clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for heart failure therapy. Provider education will also consist of the program's medical algorithm and a summary sheet on indications, outcomes, prescribing, and monitoring information

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Benjamin M. Scirica, MD

Associate Professor, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2022P002809

Identifier Type: -

Identifier Source: org_study_id