Heart Failure Clinical Trial
COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
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).
Full 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
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
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There is 1 Location for this study
Boston Massachusetts, 02115, United States More Info
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