Clinical trial NCT05734690: COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
Official title: COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Eli Lilly and Company
First posted: 2023-02-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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

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:

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

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

Primary outcomes:
measure: Primary Endpoint
timeFrame: 3-months following randomization
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 6-months following randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: