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Can a heart drug save lives in septic shock? new trial aims to find out.

NCT ID NCT04031573

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

429 people

The number who actually took part.

Started

Feb 2021

Finished

Apr 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Henri Mondor Hospital

    Créteil, 94000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.