Brigham Research Institute (BRI) - Brigham and Women's Hospital

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

Purpose

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).

Condition

Heart Failure

Eligibility

Eligible Ages: Between 18 Years and 90 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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 Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115

Contact:
Alexander J Blood

More Details

Status: Recruiting
Sponsor: Brigham and Women's Hospital

Study Contact

Daniel Gabovitch, MGB
6177633692
dgabovitch@bwh.harvard.edu

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.