Back to resultsCOPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure (COPILOT-HF)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SGLT2i, beta blocker, ARNI, MRA, MTD
Education-First
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medication & Education-First
Education-First
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary Endpoint
Any Intensification of guideline-directed medical therapy, which includes any initiation or titration of a GDMT medication.
Full Information
NCT ID
NCT05734690
First Posted
February 9, 2023
Last Updated
May 19, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Boehringer Ingelheim, Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05734690
Brief Title
COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
Acronym
COPILOT-HF
Official Title
COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Boehringer Ingelheim, Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medication & Education-First
Arm Type
Experimental
Arm Description
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.
Arm Title
Education-First
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SGLT2i, beta blocker, ARNI, MRA, MTD
Intervention Description
Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.
Intervention Type
Behavioral
Intervention Name(s)
Education-First
Intervention Description
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 Outcome Measure Information:
Title
Primary Endpoint
Description
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 Outcome Measure Information:
Title
Secondary Endpoint
Description
Any Intensification of guideline-directed medical therapy, which includes any initiation or titration of a GDMT medication.
Time Frame
6-months following randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Gabovitch, MGB
Phone
6177633692
Email
dgabovitch@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Blood, MD, MSc
Phone
617-732-7144
Email
ablood@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander J Blood
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
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