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

Heart Failure Clinical Trial

— COPILOT-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734690
• Other study ID #: 2022P002809
• Status: Recruiting
• Phase: Phase 4
• Start date: May 5, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: Brigham and Women's Hospital
• Contact: Daniel Gabovitch, MGB
• Phone: 6177633692
• Email: dgabovitch[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boehringer Ingelheim, Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

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