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

Brigham and Women's Hospital503 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

503

Conditions

Heart Failure

Interventions

SGLT2i, beta blocker, ARNI, MRA, MTDDRUG

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

Education-FirstBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 3-months following randomization

Secondary Outcomes

Secondary Endpoint

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

Time frame: 6-months following randomization

Data from ClinicalTrials.gov

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