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

NCT03456856 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20160231
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Heart Failure (HF)

Keywords

Cardiac; Congestive; Decompensation; Heart Failure; Left-Sided; Myocardial; Corlanor; Ivabradine; African American; Black; Michigan

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Heart Rate (HR) at 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).

  Day1 (baseline), Day 57

Study Arms (1)

Ivabradine

EXPERIMENTAL

The starting dose of ivabradine was 5 mg twice daily (BID), although investigators had the discretion to start participants at 2.5 mg BID if participant had a history of conduction defects, or bradycardia that could lead to hemodynamic compromise. Dose was adjusted at Day 15 (and at any other clinical visit) between 2.5 - 7.5 mg BID based on heart rate and signs/symptoms of bradycardia.

Drug: Ivabradine

Interventions

Ivabradine DRUG

Film-coated tablets taken orally with food twice a day. Tablets supplied in strengths of 5.0 mg and 7.5 mg. 5.0 tablets were split into equal halves for dosages of 2.5 mg.

Also known as: Corlanor®

Ivabradine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent/assent prior to initiation of any study specific activities/ procedures
• Male or female subject ≥ 18 years of age, describing self as African American/Black
• Must have a diagnosis of heart failure (HF) confirmed by medical records, be in stable condition, and treated with stable optimal pharmacological therapy as per their personal physician's care.
• Left ventricular ejection fraction (LVEF) ≤ 35% confirmed by investigator
• New York Heart Association (NYHA) class II to IV assessed at the time of screening
• Electrocardiogram (ECG) documentation at the time of screening of sinus rhythm with resting heart rate (HR) ≥ 70 bpm by local ECG reading
• Must be able to complete a 6-minute walk test (6MWT) and wear an accelerometer

You may not qualify if:

• Recent myocardial infarction (≤ 2 months) or stroke (≤ 1 month) prior to enrollment
• If the subject received within 3 months before or is scheduled to receive within 42 days after enrollment any of the following: revascularization, ventricular assist device, continuous or intermittent inotropic therapy, hospice care, major organ transplant, or is receiving renal replacement therapy by dialysis
• If the subject received implantation of a cardioverter defibrillator or cardiac resynchronization therapy within 42 days before or is scheduled to receive implantation of a cardioverter defibrillator or cardiac resynchronization therapy within 42 days after enrollment
• Severe primary valve disease or scheduled for surgery for valvular heart disease
• Pacemaker with atrial or ventricular pacing (except bi-ventricular pacing) \>40% of the time, or with a stimulation threshold at the atrial or ventricular level ≥ 60 bpm
• Permanent atrial fibrillation or flutter
• Sick sinus syndrome, sinoatrial block, or second and third degree atrio-ventricular block
• History of symptomatic or sustained (≥ 30 sec) ventricular arrhythmia unless a cardioverter defibrillator was implanted
• History of congenital QT syndrome
• Any cardioverter defibrillator shock experienced within 1 month of enrollment
• Hypertrophic obstructive cardiomyopathy, active myocarditis or constrictive pericarditis, or clinically significant congenital heart disease
• Chronic antiarrhythmic therapy (except digitalis)
• Scheduled outpatient intravenous (IV) infusions for HF (eg, inotropes,vasodilators \[eg, nesiritide\], diuretics) or routinely scheduled ultrafiltration
• Evidence of digitalis intoxication within 7 days prior to screening
• Systolic blood pressure \> 180 mm Hg or \< 90 mm Hg, or diastolic blood pressure \> 110 mm Hg or \< 50 mm Hg at any time during the screening phase

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Research Site

Wilmington, Delaware, 19803, United States

Location

Research Site

Detroit, Michigan, 48202, United States

Location

Research Site

Buffalo, New York, 14215, United States

Location

Related Publications (1)

• 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.

  PMID: 32808163 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Heart Failure

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: September 28, 2017
• Primary Completion: April 19, 2019
• Study Completion: May 20, 2019
• Last Updated: October 28, 2021
• Results First Posted: April 7, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

US (3)