A Study of Ivabradine in African-American/Black's With Heart Failure & Left Ventricular Systolic Dysfunction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03456856|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 14, 2018
This study is a prospective, single-site, open-label, single-arm intervention study in African-American/Black subjects with HFrEF nested in the Henry Ford Heart Failure Pharmacogenomics Registry, and will be conducted at the Henry Ford Health System in Detroit, MI.
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure (HF)||Drug: 5mg Ivabradine||Phase 4|
The goal of this study is to determine the impact of adding ivabradine therapy to the standard of care (SOC) in African-American/Black subjects with HF and reduced ejection fraction (HFrEF) on changes in heart rate (HR) from baseline (SOC alone). Changes in HR from baseline will be correlated with the genetic background of the studied population, as well as with the changes from baseline in activity level of the subjects, as measured by both a standard 6-minute walk distance and an accelerometer device.
The primary hypothesis is that ivabradine effectively reduces HR between baseline and day 57 in African-American/Black subjects. Because mean reductions of approximately 5 beat per minute (bpm) have been observed in the overall placebo-treated subjects in the SHIFT study as well as in the placebo-treated subjects of the subgroup analysis of non-African-American/Black subjects enrolled in the SHIFT study, we will test whether the mean reduction with ivabradine exceeds 5 bpm, and estimate the degree to which the mean reduction with ivabradine exceeds 5 bpm.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Single-arm, Single Center Study Assessing the Efficacy and Safety of Ivabradine (Corlanor) in African-American/Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction|
|Actual Study Start Date :||September 28, 2017|
|Estimated Primary Completion Date :||September 23, 2018|
|Estimated Study Completion Date :||September 23, 2018|
Experimental: Initial Dose: 5 mg BID
5mg Ivabradine: On day 1, eligible subjects with confirmed sinus rhythm and HR ≥ 70 bpm will be enrolled into a 57-day open-label treatment period. The starting dose of ivabradine is 5 mg twice daily (BID).
2.5mg Ivabradine: In subjects with a history of conduction defects, or in subjects in whom bradycardia could lead to hemodynamic compromise, therapy is to be initiated at 2.5 mg BID.
Changes in HR from baseline will be correlated with the genetic background of the studied population, as well as with the changes from baseline in activity level of the subjects, as measured by both a standard 6-minute walk distance and an accelerometer device.
Drug: 5mg Ivabradine
On day 15, the 5mg dose will be titrated according to HR :
HR ≥ 60 bpm 7.5 mg BID HR ≥ 50 bpm, < 60 bpm 5.0 mg BID HR < 50 bpm and/or signs or symptoms of bradycardia 2.5 mg BID
Ivabradine dose levels can be adapted to HR at any clinical visit if necessary.
Other Name: Corlanor
- Change in HR from baseline to day 57 [ Time Frame: 57 days ]Determine whether ivabradine effectively reduces HR from baselineto day 57 in African-American/Black subjects.
- Change in HR from baseline to day 57 among African-American/Black subjects associated with proportion of genetic heritage background. [ Time Frame: 57 days ]Assess association of proportion of African-American/Black subjects with HR lowering.
- Change in HR from baseline to day 57 among African-American/Black subjects with ≥ 85% proportion of genetic background and African-American/Black subjects with < 85% proportion of genetic background [ Time Frame: 57 days ]Assess association of proportion of African-American/Black subjects with HR lowering.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456856
|Contact: Amgen Call Centerfirstname.lastname@example.org|
|United States, Michigan|
|Detroit, Michigan, United States, 48202|