Trial · NCT03168529
Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit
NCT03168529, Phase 4, Terminated, Phillip Levy; results first posted 2025-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit. Trials, record NCT03168529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03168529
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit
- NCT number
- NCT03168529
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 19 participants, actual
- Lead sponsor
- Phillip Levy
- Conditions
- Heart Failure
- Interventions
- Ivabradine, Placebo
- First posted
- 2017-05-30
- Last updated
- 2026-09-11
- Results first posted
- 2025-06-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Heart Rate | Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2). | Change in heart rate from final visit to baseline visit, measured by 12-lead ECG and Zio® patch. |
| Secondary | Change in Heart Rate in Self-identified African Americans | Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2). | Change in heart rate in self-identified African Americans from final visit to baseline visit, measured by 12-lead ECG and Zio® patch. |
| Other | Change in NT-proBNP | 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. |
| Other | Change in Hs-TnT | 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. |
| Other | Safety: Unplanned Medical Care | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Heart Rate | Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2). | Only 19 patients were enrolled. Sample size was too small to perform a formal analysis. | bpm | MEDIAN |
| SECONDARY | Change in Heart Rate in Self-identified African Americans | Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2). | 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. | beats per minute | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in NT-proBNP | Biomarkers will be drawn at baseline and at day 28 (+/-2). | |||
| OTHER_PRE_SPECIFIED | Change in Hs-TnT | Biomarkers will be drawn at baseline and at day 28 (+/-2). | |||
| OTHER_PRE_SPECIFIED | Safety: Unplanned Medical Care | Recording of unplanned medical visits from baseline to final visit (Day 28 (+/- 2)). | unplanned medical visits | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Heart Rate | Ivabradine (Corlanor) | 88 | Full Range 81 to 97 | bpm | |
| Change in Heart Rate | Placebo | 85 | Full Range 81 to 91 | bpm | |
| Change in Heart Rate in Self-identified African Americans | Ivabradine (Corlanor) | 88 | Full Range 81 to 97 | beats per minute | |
| Change in Heart Rate in Self-identified African Americans | Placebo | 85 | Full Range 81 to 91 | beats per minute | |
| Safety: Unplanned Medical Care | Ivabradine (Corlanor) | 0 | unplanned medical visits | ||
| Safety: Unplanned Medical Care | Placebo | 0 | unplanned medical visits |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ivabradine (Corlanor) | 13 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Ivabradine (Corlanor) | 13 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Ivabradine (Corlanor) | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ivabradine (Corlanor) | 0 | 13 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Ivabradine (Corlanor) | 0 | 13 |
| Total, other adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Ivabradine (Corlanor) | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ivabradine (Corlanor) vs Placebo: deaths from any cause | Trial comparisons |
| Ivabradine (Corlanor) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03168529
GET https://conductscience.org/api/trials/v1/NCT03168529/registered