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

NCT ID: NCT07217106

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 342 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-03
• Study Completion Date: 2024-07-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CLCZ696BUS36

Identifier Type: -

Identifier Source: org_study_id