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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05734690

Collaborator

Boehringer Ingelheim (Industry)

500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: SGLT2i, beta blocker, ARNI, MRA, MTD Behavioral: Education-First	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Primary Endpoint [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 Outcome Measures

Secondary Endpoint [6-months following randomization]
Any Intensification of guideline-directed medical therapy, which includes any initiation or titration of a GDMT medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Brigham and Women's Hospital
Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin M. Scirica, MD, Associate Professor, Harvard Medical School, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT05734690

Other Study ID Numbers:

2022P002809

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Heart Failure

Adrenergic beta-Antagonists

Study Results

No Results Posted as of Feb 21, 2023