Heart FailurePhase 4COPILOT-HFNCT05734690
COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
A Phase 4 study testing SGLT2i, beta blocker, ARNI, MRA, MTD and Education-First in people with Heart Failure, run by Brigham and Women's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- SGLT2i, beta blocker, ARNI, MRA, MTD and Education-First
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to 9 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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).
Read the 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
- Conditions
- Heart Failure
- Being tested
- SGLT2i, beta blocker, ARNI, MRA, MTD, Education-First
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-FirstBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Medication & Education-First | Experimental | 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. Receives: Drug: SGLT2i, beta blocker, ARNI, MRA, MTD |
| Education-First | Active comparator | 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. Receives: Drug: SGLT2i, beta blocker, ARNI, MRA, MTD; Behavioral: Education-First |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months following randomization
Secondary outcomes (1)
Secondary Endpoint
Any Intensification of guideline-directed medical therapy, which includes any initiation or titration of a GDMT medication.
Measured: 6-months following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start5 May 2023
- Primary completion19 May 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Eli Lilly and Company
- Responsible party
- Principal investigator, Benjamin M. Scirica, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734690
- Sponsor's protocol ID
- 2022P002809
- Acronym
- COPILOT-HF
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blood AJ, Unlu O, Ostrominski JW, Hassan S, Nichols H, Subramaniam S, Gabovitch D, Chasse J, McPartlin M, Figueroa C, Collins E, Twining M, Varugheese M, Wagholikar K, Cannon CP, Desai AS, Scirica BM. Rationale and Design of the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure. Clin Cardiol. 2026 Feb;49(2):e70222. doi: 10.1002/clc.70222.
PubMed 41652651
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
- ClinicalTrials.gov ID
- NCT05734690
- Acronym / sponsor ID
- COPILOT-HF / 2022P002809
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Eli Lilly and Company
- Study start
- 5 May 2023 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medication & Education-First | Experimental | Drug: SGLT2i, beta blocker, ARNI, MRA, MTDPatient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. |
| Education-First | Active comparator | Drug: SGLT2i, beta blocker, ARNI, MRA, MTD, Behavioral: Education-FirstPatient 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2i, beta blocker, ARNI, MRA, MTDImmediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. | Drug | Education-First, Medication & Education-First |
| Education-FirstFor 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 | Behavioural | Education-First |
Primary outcome
Primary Endpoint
Time frame: 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.
1 secondary outcome
Secondary Endpoint
Time frame: 6-months following randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 41652651Blood AJ, Unlu O, Ostrominski JW, Hassan S, Nichols H, Subramaniam S, Gabovitch D, Chasse J, McPartlin M, Figueroa C, Collins E, Twining M, Varugheese M, Wagholikar K, Cannon CP, Desai AS, Scirica BM. Rationale and Design of the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure. Clin Cardiol. 2026 Feb;49(2):e70222. doi: 10.1002/clc.70222.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT2i, beta blocker, ARNI, MRA, MTD and Education-First in people with Heart Failure, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 3-months following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.