Trial Outcomes & Findings for A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction. (NCT NCT03456856)

Last Updated: 2021-10-28

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Day1 (baseline), Day 57

Results posted on

2021-10-28

Participant Flow

A total of 30 participants were enrolled at 2 centers in the United States.

Participant milestones

Participant milestones
Measure	Ivabradine 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.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ivabradine 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.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ivabradine n=30 Participants 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.
New York Heart Association (NYHA) Class NYHA Class II	22 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA Class III	8 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA Class IV	0 Participants n=5 Participants
Primary Cause of Heart Failure Ischemic heart disease	5 Participants n=5 Participants
Primary Cause of Heart Failure Non-ischemic heart disease	25 Participants n=5 Participants
Left Ventricular Ejection Fraction	25.6 percentage total blood in left ventricle STANDARD_DEVIATION 6.8 • n=5 Participants
Baseline Heart Rate	83.6 beats per minute STANDARD_DEVIATION 8.9 • n=5 Participants
Baseline Systolic Blood Pressure	126.8 mmHg STANDARD_DEVIATION 17.1 • n=5 Participants
Baseline Diastolic Blood Pressure	73.0 mmHg STANDARD_DEVIATION 5.7 • n=5 Participants
Age, Continuous	55.7 years STANDARD_DEVIATION 12.6 • n=5 Participants
Age, Customized 18-64 years	24 Participants n=5 Participants
Age, Customized 65-74 years	5 Participants n=5 Participants
Age, Customized 75-84 years	0 Participants n=5 Participants
Age, Customized >=85 years	1 Participants n=5 Participants
Age, Customized Unknown	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA Class I	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day1 (baseline), Day 57

Population: Full analysis set which included all enrolled participants.

Outcome measures

Outcome measures
Measure	Ivabradine n=30 Participants 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.
Change From Baseline in Heart Rate (HR) at Day 57	-9.5 beats per minute Standard Error 1.7

Adverse Events

Ivabradine

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ivabradine n=30 participants at risk 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.
Metabolism and nutrition disorders Dehydration	3.3% 1/30 • Day 1 up to Day 87 (30 days after the last dose of IP) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Ivabradine n=30 participants at risk 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.
Nervous system disorders Dizziness	13.3% 4/30 • Day 1 up to Day 87 (30 days after the last dose of IP) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	6.7% 2/30 • Day 1 up to Day 87 (30 days after the last dose of IP) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 2/30 • Day 1 up to Day 87 (30 days after the last dose of IP) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER