CompletedNot Applicable

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

United States342 participantsStarted 2024-03-03

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Up to approximately 16 weeks

Trial details

NCT IDNCT07217106

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-01