NCT03456856

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

Completed Phase 4 Results posted Last updated 28 October 2021

What this trial tests

Phase 4 trial testing Ivabradine in Heart Failure (HF) in 30 participants. Completed in 20 May 2019.

Timeline

28 September 2017

Primary endpoint
19 April 2019

20 May 2019

Quick facts

Lead sponsor	Amgen
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	28 September 2017
Primary completion	19 April 2019
Estimated completion	20 May 2019
Sites	3 locations across United States

Drugs / interventions tested

• Ivabradine (IVABRADINE) — full drug profile →

Conditions studied

• Heart Failure (HF) — all drugs for Heart Failure (HF) →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 100, any sex, with Heart Failure (HF). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Heart Rate (HR) at Day 57 Primary · Day1 (baseline), Day 57

Summary is based on observed data, and no imputation is used for missing values. Least-square mean is from the repeated measures model which includes scheduled visits and baseline HR measurement as covariates. The mean change from baseline in heart rate is compared to -5 beats/min which is observed in the placebo group in the Systolic Heart Failure Treatment with the IF Inhibitor Ivabradine Trial (SHIFT) study ( NCT02441218, PMID 20801500).

Group	Value	95% CI
Ivabradine	-9.5	± 1.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 up to Day 87 (30 days after the last dose of IP). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ivabradine

Serious: 1/30 (3%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	Ivabradine
Dehydration	Metabolism and nutrition disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Ivabradine
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Dehydration.

Data from ClinicalTrials.gov NCT03456856 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Lanfear DE, Neaton KR, Lu C, Liu Y, et al · · 2020 · PMID 32808163 · DOI 10.1007/s40119-020-00196-1