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OpenTrials
Completed

NCT Number: NCT05734690

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

The primary objectives are:

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Primary Endpoint

    Time frame: 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 outcomes

  1. Secondary Endpoint

    Time frame: 6-months following randomization

    Any Intensification of guideline-directed medical therapy, which includes any initiation or titration of a GDMT medication.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boehringer Ingelheim
  • Eli Lilly and Company

Registry information

Acronym: COPILOT-HF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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