Can a heart drug tame sepsis? new trial aims to find out
NCT ID NCT05882708
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 172 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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May 2027
An estimate. End dates often move.
- 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.
Show the full entry requirements Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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the Affiliated Panyu central Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, 510000, China
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the Second Affiliated Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, 510000, China
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the Third Affiliated Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, 510260, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?
- Stem cells put to the test against Sepsis's immune chaos
- 24 sensors map muscle oxygen after ACL surgery
- Can the immune system reveal who will suffer kidney injury after sepsis?