Trial · NCT02441218
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
NCT02441218, Phase 3, Completed, Institut de Recherches Internationales Servier; results first posted 2015-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study. Trials, record NCT02441218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02441218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
- NCT number
- NCT02441218
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,505 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Chronic Heart Failure
- Interventions
- Ivabradine, Placebo
- First posted
- 2015-05-12
- Last updated
- 2020-01-03
- Other registries' IDs
- eudract:2006-000708-18
- Results first posted
- 2015-06-29
- Limitations and caveats
- The section Other Adverse Events (Not including serious) has been completed by the sponsor to include only the Non Serious Adverse Events emergent on treatment during the study.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure. | All over the study (up to 42 months). | Number of patients having experienced the Primary Composite Endpoint. |
| Secondary | Cardiovascular Death | From the date of randomization until the date of death, up to 42 months | Component of the primary composite endpoint |
| Secondary | Hospitalisation for Worsening Heart Failure | From the date of randomization to the date of first documented hospitalisation, up to 42 months | |
| Secondary | All-cause Mortality | From the date of randomisation to death, up to 42 months. | |
| Secondary | Death From Heart Failure | From the date of randomisation to death, up to 42 months. | Component of cardiovascular death |
| Secondary | Hospitalisation for Any Cause | From the date of randomisation to the date of first documented hospitalisation, up to 42 months | |
| Secondary | Hospitalisation for Cardiovascular Reason | From the date of randomisation to the first documented hospitalisation, up to 42 months | |
| Secondary | Unplanned Hospitalisation for Any Cause | From the date of randomisation to the first documented hospitalisation, up to 42 months | |
| Secondary | Unplanned Hospitalisation for CV Reason | From the date of randomisation to the first documented hospitalisation, up to 42 months. | |
| Secondary | Secondary Composite Endpoint | From the date of randomisation to the date of the first event, up to 42 months | CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure. | All over the study (up to 42 months). | participants | NUMBER | |
| SECONDARY | Cardiovascular Death | From the date of randomization until the date of death, up to 42 months | participants | NUMBER | |
| SECONDARY | Hospitalisation for Worsening Heart Failure | From the date of randomization to the date of first documented hospitalisation, up to 42 months | participants | NUMBER | |
| SECONDARY | All-cause Mortality | From the date of randomisation to death, up to 42 months. | participants | NUMBER | |
| SECONDARY | Death From Heart Failure | From the date of randomisation to death, up to 42 months. | participants | NUMBER | |
| SECONDARY | Hospitalisation for Any Cause | From the date of randomisation to the date of first documented hospitalisation, up to 42 months | participants | NUMBER | |
| SECONDARY | Hospitalisation for Cardiovascular Reason | From the date of randomisation to the first documented hospitalisation, up to 42 months | participants | NUMBER | |
| SECONDARY | Unplanned Hospitalisation for Any Cause | From the date of randomisation to the first documented hospitalisation, up to 42 months | participants | NUMBER | |
| SECONDARY | Unplanned Hospitalisation for CV Reason | From the date of randomisation to the first documented hospitalisation, up to 42 months. | participants | NUMBER | |
| SECONDARY | Secondary Composite Endpoint | From the date of randomisation to the date of the first event, up to 42 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure. | Ivabradine | 793 | participants | ||
| Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure. | Placebo | 937 | participants | ||
| Cardiovascular Death | Ivabradine | 449 | participants | ||
| Cardiovascular Death | Placebo | 491 | participants | ||
| Hospitalisation for Worsening Heart Failure | Ivabradine | 514 | participants | ||
| Hospitalisation for Worsening Heart Failure | Placebo | 672 | participants | ||
| All-cause Mortality | Ivabradine | 503 | participants | ||
| All-cause Mortality | Placebo | 552 | participants | ||
| Death From Heart Failure | Ivabradine | 113 | participants | ||
| Death From Heart Failure | Placebo | 151 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ivabradine | 3,241 | |
| Overall Study | STARTED | Placebo | 3,264 | |
| Overall Study | COMPLETED | Ivabradine | 2,663 | |
| Overall Study | COMPLETED | Placebo | 2,652 | |
| Overall Study | NOT COMPLETED | Ivabradine | 578 | |
| Overall Study | NOT COMPLETED | Placebo | 612 |
Source ClinicalTrials.gov
Adverse events1,416
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ivabradine | 91 | 3,232 | 93 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 92 | 3,260 | 96 |
| other | Angina pectoris | Cardiac disorders | Ivabradine | 85 | 3,232 | 97 |
| other | Angina pectoris | Cardiac disorders | Placebo | 93 | 3,260 | 109 |
| other | Atrial fibrillation | Cardiac disorders | Ivabradine | 161 | 3,232 | 176 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 123 | 3,260 | 138 |
| other | Atrioventricular block first degree | Cardiac disorders | Ivabradine | 35 | 3,232 | 38 |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo | 36 | 3,260 | 42 |
| other | Bradycardia | Cardiac disorders | Ivabradine | 134 | 3,232 | 142 |
| other | Bradycardia | Cardiac disorders | Placebo | 26 | 3,260 | 30 |
1 to 10 of 1,416Source ClinicalTrials.gov
See all 1,416 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ivabradine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ivabradine | 2,062 | 3,232 |
| Total, other adverse events | Placebo | 2,020 | 3,260 |
| Total, serious adverse events | Ivabradine | 1,369 | 3,232 |
| Total, serious adverse events | Placebo | 1,481 | 3,260 |
Source ClinicalTrials.gov
Papers4
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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ivabradine vs Placebo: Hospitalisation for Worsening Heart Failure | Trial comparisons |
| Ivabradine vs Placebo: Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure. | Trial comparisons |
| Ivabradine vs Placebo: Unplanned Hospitalisation for CV Reason | Trial comparisons |
| Ivabradine vs Placebo: Death From Heart Failure | Trial comparisons |
| Ivabradine vs Placebo: Hospitalisation for Cardiovascular Reason | Trial comparisons |
| Ivabradine vs Placebo: Hospitalisation for Any Cause | Trial comparisons |
| Ivabradine vs Placebo: Secondary Composite Endpoint | Trial comparisons |
| Ivabradine vs Placebo: Cardiovascular Death | Trial comparisons |
| Ivabradine vs Placebo: All-cause Mortality | Trial comparisons |
| Ivabradine vs Placebo: Unplanned Hospitalisation for Any Cause | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT02441218
GET https://conductscience.org/api/trials/v1/NCT02441218/events?page=2