A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular… (NCT03456856) | Clinical Trial Compass
CompletedPhase 4
A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.
United States30 participantsStarted 2017-09-28
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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 p…