Trial Outcomes & Findings for Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit (NCT NCT03168529)
NCT ID: NCT03168529
Last Updated: 2025-06-08
Results Overview
Change in heart rate from final visit to baseline visit, measured by 12-lead ECG and Zio® patch.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2).
Results posted on
2025-06-08
Participant Flow
Participant milestones
| Measure |
Ivabradine (Corlanor)
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving active drug for study duration.
Ivabradine: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
Placebo
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving placebo for study duration.
Placebo: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules not containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
|
Overall Study
COMPLETED
|
13
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit
Baseline characteristics by cohort
| Measure |
Ivabradine (Corlanor)
n=13 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving active drug for study duration.
Ivabradine: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
Placebo
n=6 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving placebo for study duration.
Placebo: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules not containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2).Population: Only 19 patients were enrolled. Sample size was too small to perform a formal analysis.
Change in heart rate from final visit to baseline visit, measured by 12-lead ECG and Zio® patch.
Outcome measures
| Measure |
Ivabradine (Corlanor)
n=13 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving active drug for study duration.
Ivabradine: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
Placebo
n=6 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving placebo for study duration.
Placebo: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules not containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
|---|---|---|
|
Change in Heart Rate
|
88 bpm
Interval 81.0 to 97.0
|
85 bpm
Interval 81.0 to 91.0
|
SECONDARY outcome
Timeframe: Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2).Population: Data presented represent the subgroup of 18 self-identified AA. No comparison by randomized group was conducted. Because we report Median, which is a measure of central tendency not Mean, and Range, which shows low and high ends of data, not SD, removal of the 1 non-self identified AA patient from the Ivabridine group had no impact on findings; data remained the same. Because no patients were removed from Placebo group as all were self-identified AA, the data are the same as Outcome Measure 1.
Change in heart rate in self-identified African Americans from final visit to baseline visit, measured by 12-lead ECG and Zio® patch.
Outcome measures
| Measure |
Ivabradine (Corlanor)
n=12 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving active drug for study duration.
Ivabradine: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
Placebo
n=6 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving placebo for study duration.
Placebo: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules not containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
|---|---|---|
|
Change in Heart Rate in Self-identified African Americans
|
88 beats per minute
Interval 81.0 to 97.0
|
85 beats per minute
Interval 81.0 to 91.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Biomarkers will be drawn at baseline and at day 28 (+/-2).Change in NT-proBNP from baseline visit to final visit, measured and quantified using the Roche Cobas® analyzer.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Biomarkers will be drawn at baseline and at day 28 (+/-2).Change in NT-proBNP from baseline visit to final visit, measured and quantified using the Roche Cobas® analyzer.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Recording of unplanned medical visits from baseline to final visit (Day 28 (+/- 2)).Presentation for unplanned medical care in any setting within 28 (+/-2) days.
Outcome measures
| Measure |
Ivabradine (Corlanor)
n=13 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving active drug for study duration.
Ivabradine: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
Placebo
n=6 Participants
All subjects will complete the same number of follow-ups, dose titrations (if necessary) and study procedures however, subjects in this arm will be receiving placebo for study duration.
Placebo: At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules not containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
|
|---|---|---|
|
Safety: Unplanned Medical Care
|
0 unplanned medical visits
|
0 unplanned medical visits
|
Adverse Events
Ivabradine (Corlanor)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place