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Ivabradine for Heart Rate Control In Septic Shock

Study acronym: IRISS
StatusCompleted
PhasePhase 3
Started2021-02-26
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
notable
Study Status, Study Design, IPDSharing v11
Trial completed
Completion dateestimated 2026-04-22→confirmed 2026-04-14
2026-03-19
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-09-24→confirmed 2026-02-19
Completion date2024-12-24→2026-04-22
Start date2021-02-24→2021-02-26
Study sitesdetails revised at 1 of 1 site
2024-06-24
minor
Study Status, Eligibility v9
Primary completion date2023-01-24→2024-09-24
Completion date2023-03-24→2024-12-24
Eligibility criteria+523 characters
Inclusion Criteria: 18 years of age or older;, Proven or suspected site of infection;, Septic shock (defined as hypotension unresponsive to fluid [...] ng vasopressor treatment to maintain adequate blood pressure in the context of proven or suspected site of infection) for at least 62 hours and less than 24 hours; (inclusion is possible before 2 hours in case of increasing doses of norepinephrine), In sinus rhythm with heart rate ≥ 95 bpm at time of randomization;, Informed consent obtained in accordance with local regulations;, Affiliation to a social security regime. Exclusion Criteria: Age < 18 y [...] [...]
2021-07-12
minor
Study Status v8
Re-verified, no change to tracked fields
2021-03-19
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-01-01→2023-01-24
Completion date2023-03-01→2023-03-24
Start dateestimated 2021-02-01→confirmed 2021-02-24
Show 6 earlier versions
2021-01-15
minor
Study Status v6
Primary completion date2022-10-01→2023-01-01
Completion date2022-12-01→2023-03-01
Start date2020-12-01→2021-02-01
2020-10-23
minor
Study Status v5
Start date2020-09-01→2020-12-01
2020-05-19
minor
Study Status v4
Primary completion date2022-04-01→2022-10-01
Completion date2022-06-01→2022-12-01
Start date2020-03-01→2020-09-01
2020-02-07
minor
Study Status v3
Primary completion date2022-02-01→2022-04-01
Completion date2022-04-01→2022-06-01
Start date2020-01-01→2020-03-01
2019-11-22
minor
Study Status v2
Primary completion date2021-10-01→2022-02-01
Completion date2021-12-31→2022-04-01
Start date2019-11-01→2020-01-01
2019-09-26
minor
Study Status v1
Start date2019-09-01→2019-11-01
2019-07-23
minor
Original filing
Septic shock is a major health problem, with several million cases annually worldwide and a mortality approaching 45%. Tachycardia is associated with excess mortality during septic shock. This pejorative effect could be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function, and/or poorer tolerance of administered exogenous catecholamines. Recent studies suggest that controlling the heart rate with the use of beta blockers has beneficial effects on the morbidity and mortality of septic shock. However, the negative effects of beta-blockers on cardiac contractility and blood pressure complicate their use during septic shock, particularly because about one-half of patients exhibit a septic-associated systolic dysfunction, which often requires the use of inotropes. Ivabradine is a selective inhibitor of If channels in the sinoatrial node. It is a pure bradycardic agent with no deleterious effect on other aspects of cardiac function (contractility, conduction and repolarization) nor on blood pressure. Ivabradine can therefore alleviate sinus tachycardia without negative inotropic effects nor hypotension. Moreover, the improvement in diastolic function (ventricular filling) with ivabradine may increase stroke volume, even in case of severe impairment of systolic function. Controlling sinus tachycardia with ivabradine during septic shock would allow reducing cardiac metabolic demand (and potentially associated ischemic events) and improving the chronotropic tolerance of exogenous catecholamines. The effectiveness of ivabradine in controlling the heart rate was demonstrated in various clinical settings such as coronary artery disease, chronic heart failure and cardiogenic shock. Encouraging preliminary data are reported in critically ill patients.
Trial Details
NCT Number NCT04031573
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Septic Shock
Enrollment 429 participants
Start Date 2021-02-26
Primary Completion 2026-02-19 (estimated)
Study Completion 2026-04-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-03