Trial · NCT04031573
Ivabradine for Heart Rate Control In Septic Shock
NCT04031573, Phase 3, Completed, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ivabradine for Heart Rate Control In Septic Shock. Trials, record NCT04031573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04031573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ivabradine for Heart Rate Control In Septic Shock
- NCT number
- NCT04031573
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 429 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Septic Shock
- Interventions
- Ivabradine, Ivabradine, Placebo
- First posted
- 2019-07-24
- Last updated
- 2026-09-03
- Other registries' IDs
- eudract:2018-003801-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48 | hour 48 after treatment | for activity and treatment selection at interim analysis |
| Primary | Percentage of patients dead at 28 days | 28 days | for efficacy and the final analysis |
| Secondary | percentage of patients with bradycardia (heart rate <60/min), atrial fibrillation, phosphenes or blurred vision up to day-17 | Day 17 | Tolerance of ivabradine |
| Secondary | Percentage of patients with a heart rate within the target range (80-94 bpm) at hour-72 | hour-72 | percentage of heart rate measurements (assessed every 3 to 4 hours) within the target range at hour-72; changes in heart rate, mean arterial pressure and cardiac output evaluated by the area under the curve (AUC) versus time at hour-72; |
| Secondary | Organ failures free days (SOFA<3 for each organ) at day-14 and day-28, | at day-14 and day-28 | |
| Secondary | Number of catecholamines-, vasopressor- and mechanical ventilation-free days at day-14 and day-28, | at day-14 and day-28 | |
| Secondary | lactate clearance | at day-2 and day-3; | |
| Secondary | Left ventricle ejection fraction | at randomization (hour-0) , 12 hours, and 24 hours after the first administration of study drug | to assess left ventricle ejection fraction |
| Secondary | cardiac troponin assessment | a blood sample will be collected at randomization, day-2 and day-3 | a blood sample will be collected for measurement of troponin T |
| Secondary | Pharmacokinetics of ivabradine | Day-3 | A blood sample for measurement of plasma concentration of ivabradine will be collected at day-3 at three time points: just before study drug administration (5th dose), 60 minutes later, and during the next routine blood sampling at a random schedule (during the next blood sampling for clinical purposes). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04031573
GET https://conductscience.org/api/trials/v1/NCT04031573/registered