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

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: SGLT2i, beta blocker, ARNI, MRA, MTD; Behavioral: Education-First

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

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Daniel Gabovitch, MGB; Phone Number: 6177633692; Email: dgabovitch@bwh.harvard.edu
• Study Contact Backup: Name: Alexander Blood, MD, MSc; Phone Number: 617-732-7144; Email: ablood@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Alexander J Blood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	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.	3-months following randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	Any Intensification of guideline-directed medical therapy, which includes any initiation or titration of a GDMT medication.	6-months following randomization

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Eli Lilly and Company; Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Antagonists
• Other Study ID Numbers: 2022P002809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes