A Study of Accelerated Guideline-Directed Medical Therapy for Heart Failure

Novartis Pharmaceuticals342 enrolled

Overview

The aim of the study was to evaluate the efficacy and safety of a Guideline-Directed Medical Therapy (GDMT) clinic within a general cardiology practice relative to usual care. This study analyzed data from patients with heart failure (HF) who were referred to the GDMT clinic at Massachusetts General Hospital (MGH). For the comparator arm, patients in the GDMT clinic were matched to data of patients contained within in the MGH Research Patient Data Repository (RPDR).

Study Type

OBSERVATIONAL

Enrollment

342

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Diagnosis of HF, including new onset disease * Established cardiovascular follow up at the hospital * Received sub-optimal medical care defined as \<50% target doses of GDMT agents * Left ventricular ejection fraction (LVEF) \<50% Exclusion criteria: * Planned referral to the Advanced HF program * Decompensated HF * End-stage kidney disease o glomerular filtration rate (GFR) \<15 mL/min/1.73m\^2 or on renal replacement therapy * Untreated severe valvular heart disease * Advanced HF * Inotropic support * Transplant or mechanical circulatory support (MCS) planned * Enrolled in hospice or palliative care * Life expectancy \<12 months due to non-cardiovascular (CV) disease * Pericardial constriction * Hypertrophic cardiomyopathy * Unwillingness or inability to take GDMT * Pregnancy or breast feeding

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up

Class I GDMT drugs included angiotensin receptor/neprilysin inhibitor (ARNI), evidence-based beta blocker (eBBB), mineralocorticoid receptor antagonist (MRA), sodium-glucose co-transporter-2 inhibitor (SGLT2i) or renin angiotensin system inhibitor (RASi), eBBB, MRA, SGLT2i.

Time frame: Up to approximately 16 weeks

Secondary Outcomes

Number Patients Receiving 50% or More of the Target Dose of Four Class I GDMT Drugs at Final Visit of Follow-up

Time frame: Up to approximately 16 weeks

Number of Patients on a Higher Number of Therapies at Final Visit of Follow-up Compared to Baseline

Time frame: Baseline and up to approximately 16 weeks

Change From Baseline in New York Heart Association (NYHA) Classification

The NYHA classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity: Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF. Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF. Class IV - Unable to carry out any physical activity without symptoms of HF, or symptoms of HF at rest.

Time frame: Baseline and up to approximately 16 weeks

Change From Baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) Concentration

Time frame: Baseline and up to approximately 16 weeks

Change From Baseline in Echocardiography Measurement: LVEF

Data from ClinicalTrials.gov

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