Status:
COMPLETED
A Study of Accelerated Guideline-Directed Medical Therapy for Heart Failure
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 3 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT07217106
Start Date
March 3 2024
End Date
July 1 2024
Last Update
October 15 2025
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936