Can a heart drug save lives in septic shock? new trial aims to find out.
NCT ID NCT04031573
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests a drug called ivabradine in 429 adults with septic shock, a life-threatening condition where infection causes dangerously low blood pressure. Many patients develop a fast heart rate, which can worsen outcomes. Ivabradine slows the heart without weakening its pumping strength, unlike standard beta-blockers. The goal is to see if controlling heart rate this way reduces deaths at 28 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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429 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years of age or older, * Proven or suspected site of infection, * Septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure in the context of proven or suspected site of infection) for at least 2 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 years, * Cardiac arythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), sino-atrial block; 3rd degree atrioventricular block, "IRISS" protocol, version 6.0 of 30/10/2023 7/47 This document is the property of DRCD / APHP. All reproduction is strictly prohibited. * Cardiogenic shock or unstable or acute heart failure without proven or suspected infection, * Acute myocardial infarction with angiographic documentation; CCS class ≥ II angina pectoris; * Septic shock requiring vasopressor treatment for more than 24 hours, * Refractory shock with systolic arterial pressure \<90 mm Hg) despite the use of high doses of vasopressors (norepinephrine BASE or epinephrine BASE \> 2.4 µg/kg/min; these doses should be multiplied by two for noradrenaline salt (tartrate or bitartrate), * Co-treatment with drugs inducing bradycardia, QT lengthening or strong inhibition of CYP4503A4, pacemaker, defibrillator, kalemia \<3 mM, * Co-treatment with verapamil or diltiazem (which are moderate CYP4503A4 inhibitors with heart rate reducing properties) * Known pregnancy, breast feeding, women with childbearing potential will be tested for pregnancy and excluded if pregnant, * Known allergy to ivabradine or to any of the excipients, retinitis pigmentosa, congenital galactosemia, lactase deficiency, glucose or galactose malabsorption, * Severe chronic renal failure (creatinine clearance \<15 ml/min) or hepatic failure (prothrombin time \<20%), * Enteral feeding impossible, vomiting, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption syndrome, * Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (\<7 g/dL), * Prior enrolment in the trial, participation in another interventional study on septic shock, * Known legal incapacity (patients under guardianship or curatorship), * Decision to limit full care taken before obtaining informed consent, * Patient under AME (state emergency medical help), * Lack of affiliation to social security.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Henri Mondor Hospital
Créteil, 94000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Chilling fever: can cooling septic shock patients save lives?
- Bedside eye scans may reveal hidden blood flow problems in septic shock
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a bedside ultrasound predict which septic shock patients will stop breathing on their own?
- Can a computer model speed up sepsis blood tests?