A Phase 4, Open-Label, Single-Arm Study Assessing the Efficacy and Safety of Ivabradine in African American Patients with Heart Failure and Reduced Ejection Fraction.

ABSTRACT:

Introduction

There are limited data on ivabradine therapy in black patients and none in African Americans. We performed an open-label, prospective study at two centers in the United States. African American patients with heart failure (HF) (N = 30), left ventricular ejection fraction ≤ 35%, and in sinus rhythm with resting heart rate (HR) ≥ 70 bpm received ivabradine 2.5-7.5 mg twice daily for 57 days.

Methods

The primary endpoint was change in HR from baseline to day 57, compared with the -5 bpm change observed in the absence of ivabradine in the placebo group of the SHIFT study. The safety endpoint was treatment-emergent adverse events (TEAEs). Exploratory endpoints were change from baseline to day 57 in 6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e.

SUBMITTER: Lanfear DE 

PROVIDER: S-EPMC7584707 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature