A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.

Phase 4 Completed 30 enrolled Amgen

NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, open-label, single-arm intervention study in African-American/Black subjects with heart failure and reduced ejection fraction (HFrEF). There will be a 7-day screening period, a 57-day open-label treatment period, and a safety follow-up at day 87 or 30 days after the last administration of the investigational product.

Timeline

Start: 2017-09-28
Primary completion: 2019-04-19
Completion: 2019-05-20

Outcome

Met primary endpoint

registry Ivabradine: -9.5 (Standard Error 1.7) beats per minute NCT03456856 ↗

registry Ivabradine; p = 0.013; least square mean difference -4.5 (95% CI -8.0 to -1.0) NCT03456856 ↗

Publications

Background Lanfear DE, Neaton KR, Lu C, Liu Y, Dent-Acosta RE. 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. Cardiol Ther. 2020 Dec;9(2):561-568. doi: 10.1007/s40119-020-00196-1. Epub 2020 Aug 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivabradine	Small molecule	2.5 mg	Oral
Subject	Ivabradine	Small molecule	5 mg	Oral
Subject	Ivabradine	Small molecule	7.5 mg	Oral