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

NCT07217106 | Completed

• 1 other identifier: CLCZ696BUS36
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Keywords

Medical therapy; Implementation; Cardiac remodeling

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 16 weeks

Secondary Outcomes (9)

• 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

• 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

Study Arms (2)

GDMT Clinic

Patients with HF with an abnormal ejection fraction (EF) who were referred to the GDMT clinic and underwent rapid guideline-recommended medication titration.

Usual Care (RPRD)

Patients from the MGH RPRD receiving care since the 2022 United States HF guideline update who were matched in a 2:1 fashion to GDMT clinic patients. Matching was based on age, sex, race, duration of HF, ischemic heart disease, diabetes mellitus, atrial fibrillation and baseline EF.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, non-interventional cohort study.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 15, 2025
• Study Start: March 3, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (1)