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Can a heart drug tame sepsis? new trial aims to find out

NCT ID NCT05882708

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether ivabradine, a drug that slows heart rate without weakening the heart's pumping strength, can help people with sepsis. Sepsis is a life-threatening infection that often causes a dangerously fast heart rate. The trial will enroll 172 adults in intensive care and compare ivabradine to a placebo, measuring heart rate, blood pressure, and other heart function over 96 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivabradine
What this could lead to
If it works, this could point toward a safer way to control heart rate in sepsis patients, potentially reducing deaths.
What could go wrong
This is a mid-stage trial with only 172 participants, so results may not apply to all sepsis patients. Ivabradine may not improve survival or could cause side effects like slow heart rate.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 172 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

May 2027

An estimate. End dates often move.

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: 1. Adult patients aged 18 years or above. 2. Being treated in an intensive care unit. 3. Sepsis is diagnosed according to Sepsis-3.0 criteria, which is defined as patients requiring antimicrobial agents due to confirmed or suspected infection, acute increase in the SOFA score at least 2 points. 4. Mean arterial pressure (MAP) is maintained ≥65 mmHg with adequate volume resuscitation and vasopressor therapy. Volume resuscitation is considered adequate when Central Venous Pressure (CVP) \> 8mmHg, global end-diastolic volume index (GEDI) \> 680ml/m2 and resting inferior vena cava (IVC) diameter \> 1.5cm. 5. Patients are in a relatively stable period of hemodynamics, as defined that the targe mean arterial pressure are maintained with the same dosage of vasopressors for at least 2 h. 6. Sinus rhythm with heart rate ≥ 95bpm maintain for at least 2 hours but less than 72 hours. Exclusion Criteria: 1. Patients who had received ivabradine therapy or known allergy to it prior to randomization. 2. Patients with severe liver dysfunction (Child-C grade). 3. Patients with a history of pre-existing chronic renal failure (glomerular filtration rate less than 15 ml/min/1.73 m2), except patients treated with continuous renal replacement therapy (CRRT). 4. Patients with known seizure disorder. 5. Patients with any contraindication to gastrointestinal drug administration. 6. Pregnant or lactating patients. 7. patients requiring the use of potent cytochrome CYP3A4 inhibitors such as antifungals of the azole-type (specifically ketoconazole and itraconazole), macrolide antibiotics (specifically clarithromycin and erythromycin) and HIV protease inhibitors (specifically nelfinavir and ritonavir). 8. Patients with active bleeding; 9. Patients with cardiac dysfunction caused by non-septic causes such as recent (\< 2months) acute myocardial infarction, chronic cardiac dysfunction (NYHA Class Ⅳ), congenital heart disease, pericardial tamponade, severe aortic regurgitation and aortic coarctation before enrollment. 10. Patients with sinoatrial block, sick sinus syndrome, atrioventricular block or heart rate dependence on pacemaker. 11. Patients with refractory shock, which may be considered if one of the following conditions still exists in spite of active volume resuscitation, high doses of vasoactive drugs (VIS score \>120), and other regular therapy: 1) Worsening hypotension (MAP\<65mmHg); 2) Lactate persistence\>5mmol/L (two times in a row with an interval of more than 30min), and a progressive upward trend; 3) Mixed venous blood oxygen saturation (SvO2) sustained \<55% (more than two consecutive times, more than 30min apart), and progressive deterioration. The above conditions lasted for more than 5 hours. 12. Use of beta blockers within 24 hours before enrollment. 13. Pheochromocytoma patients. 14. After cardiopulmonary resuscitation. 15. Patients who have been enrolled in another interventional clinical study.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • the Affiliated Panyu central Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • the Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • the Third Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510260, China

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