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

NCT05734690 | Completed Phase 4 FDA Drug

• 1 other identifier: 2022P002809
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Endpoint

  6-months following randomization

Study Arms (2)

Medication & Education-First

EXPERIMENTAL

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

Education-First

ACTIVE COMPARATOR

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; Behavioral: Education-First

Interventions

Education-First 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

Education-First

SGLT2i, beta blocker, ARNI, MRA, MTD DRUG

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

Education-First; Medication & Education-First

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Boehringer Ingelheim: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Blood AJ, Unlu O, Ostrominski JW, Hassan S, Nichols H, Subramaniam S, Gabovitch D, Chasse J, McPartlin M, Figueroa C, Collins E, Twining M, Varugheese M, Wagholikar K, Cannon CP, Desai AS, Scirica BM. Rationale and Design of the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure. Clin Cardiol. 2026 Feb;49(2):e70222. doi: 10.1002/clc.70222.

  PMID: 41652651 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Adrenergic beta-Antagonists; tocilizumab; Maximum Tolerated Dose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Toxicity Tests; Investigative Techniques; Toxicological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Model Details: One group of patients, upon randomization, will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. The comparator group 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.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: May 5, 2023
• Primary Completion: May 19, 2025
• Study Completion: June 9, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)