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

Completed

• Conditions: Heart Failure

• Registration Number: NCT07217106
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-03
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2025-10
• Study First Submitted: 2025-10-13
• Study First Submitted QC: 2025-10-13
• Last Update Submitted: 2025-10-13
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up	Up to approximately 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number Patients Receiving 50% or More of the Target Dose of Four Class I GDMT Drugs at Final Visit of Follow-up	Up to approximately 16 weeks
Number of Patients on a Higher Number of Therapies at Final Visit of Follow-up Compared to Baseline	Baseline and up to approximately 16 weeks
Change From Baseline in New York Heart Association (NYHA) Classification	Baseline and up to approximately 16 weeks	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.
Change From Baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) Concentration	Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: LVEF	Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular End-Diastolic Volume Index (LVEDVi)	Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular End-Systolic Volume Index (LVESVi)	Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Atrial Volume Index (LAVi)	Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular Mass Index (LVMi)	Baseline and up to approximately 16 weeks

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States