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Phase 4 N=30 Treatment

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

Heart Failure (HF)

Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Apr 2020
Primary outcome: Primary: Change From Baseline in Heart Rate (HR) at Day 57 — -9.5 beats per minute — p=0.013

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ivabradine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Amgen
Primary completion
Apr 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Heart Rate (HR) at Day 57
-9.5 0.013 sig

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 110 mm Hg or < 50 mm Hg at any time during the screening phase
  • Known untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease
  • Have known acute or serious co-morbid condition (e.g, major infection or hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction) that may interfere with the study, or severe concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 1 year or malignancy within 5 years prior to enrollment with the following exceptions: localized basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia
  • Subjects taking QT prolonging medicinal products for cardiovascular (e.g, but not limited to, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone) or non-cardiovascular disease (e.g, but not limited to, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, IV erythromycin).
  • Subjects exposed to a strong CYP3A4 inhibitor (examples of strong CYP3A4 inhibitors include; azole antifungals [eg, itraconazole], macrolide antibiotics [e.g, clarithromycin, telithromycin], human immunodeficiency virus (HIV) protease inhibitors, [eg, nelfinavir], and nefazodone]) within 14 days prior to enrollment, or to a strong CYP3A4 inducer (examples of CYP3A4 inducers include; St. John's wort, rifampicin, barbiturates, and
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Data sourced from ClinicalTrials.gov (NCT03456856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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