A multicenter, prospective, randomized, placebo-controlled, double-blind, multi-arm, multi-stage clinical trial of Ivabradine for heart Rate control In Septic shock [IRISS]
Septic shock is a life-threatening medical emergency. It happens when the body has an extreme reaction to an infection, leading to dangerously low blood pressure and a very fast heart rate. When the heart beats too fast for too long, it gets exhausted and struggles to pump blood properly to vital organs. This Phase 3 trial is testing a medicine called ivabradine (Procoralan). Ivabradine is designed to slow the heart rate down without lowering blood pressure. Patients in the intensive care unit (ICU) will receive either ivabradine or a dummy tablet (placebo) alongside their standard medical treatment. Researchers want to see if bringing the heart rate into a safer target zone (80 to 94 beats per minute) within 48 hours helps patients survive and recover. The medical team will track each patient's progress over 28 days to measure safety, recovery, and overall survival.
At a glance
What is this study about?
Septic shock is a critical condition treated in intensive care units (ICUs). When someone gets a severe infection, their immune system can go into overdrive. This causes blood pressure to plummet, and the heart races to try to keep blood moving to vital organs like the brain, kidneys, and liver. While a fast heartbeat helps at first, racing continuously at very high speeds puts dangerous stress on the heart muscle and can lead to organ failure.
Ivabradine is a medication already used for certain heart conditions. It works specifically to slow down the heart's natural pacemaker without weakening the force of heartbeats or dropping blood pressure further. In this study, doctors want to find out whether giving ivabradine to patients in septic shock helps their heart rest and pump more effectively.
The trial is 'double-blind' and 'placebo-controlled'. This means half the patients receive ivabradine tablets and the other half receive a dummy pill with no active medicine. Neither the patients, their families, nor the treating doctors will know who is receiving which treatment until the trial ends. This approach ensures the results are completely fair and unbiased.
By carefully checking heart rates during the first 48 hours and tracking health outcomes over 28 days, researchers hope to discover if ivabradine can save lives and reduce long-term organ damage. If successful, this trial could provide NHS intensive care teams with a valuable new tool for treating severe infections.
Key takeaways
- The IRISS trial tests if the heart medicine ivabradine helps adults with septic shock in intensive care.
- The main goal is to safely slow a racing heart to between 80 and 94 beats per minute.
- Patients are randomly selected to receive either ivabradine or a dummy pill (placebo) alongside full standard care.
- Doctors will monitor heart response over 48 hours and follow health outcomes for 28 days.
- Participation is strictly monitored in the ICU, and taking part is completely voluntary.
Who may be eligible?
This trial is open to adults aged 18 and older who have been admitted to an intensive care unit with septic shock and a dangerously fast heart rate. Both men and women can take part.
Because septic shock develops very quickly and makes people critically unwell, patients are often unconscious or unable to make decisions for themselves when they arrive in the ICU. In these cases, doctors will discuss taking part with close family members or legal representatives before enrolling the patient.
People may not be able to join if they have specific pre-existing heart conditions (such as a naturally very slow heartbeat or certain rhythm problems) or if they take medications that cannot safely be mixed with ivabradine. The ICU doctors will carefully review all medical history to make sure joining the trial is safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- The patient is aged 18 or older.
- The patient is currently being treated in an intensive care unit (ICU).
- The patient has been diagnosed with septic shock from an infection.
- The patient has a persistent, dangerously fast heart rate.
- The patient has no known medical reasons that make ivabradine unsafe to use.
What does participation involve?
Because this trial takes place entirely in the intensive care unit, there are no extra hospital visits required. While in the ICU, participants receive either ivabradine or a placebo tablet (crushed or dissolved if the person cannot swallow) alongside their regular intensive care treatments. The medical team monitors the patient's heart rate, blood pressure, and organ function around the clock. The main treatment phase focuses on the first 48 hours to see how quickly the heart rate responds. Doctors continue to check blood tests and vital signs throughout the hospital stay, and the study team tracks each patient's overall health and recovery for a total of 28 days.
Potential risks and benefits
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Common questions
What is septic shock?
Septic shock is a life-threatening stage of sepsis where a severe infection causes blood pressure to drop dangerously low and makes the heart beat very fast.
What is a placebo?
A placebo is a dummy treatment designed to look identical to the real medicine but containing no active ingredients. It helps researchers prove whether the real medicine truly works.
How can someone join if they are too ill to give consent?
In intensive care, doctors follow strict legal rules. They will consult the patient's family, partner, or an independent doctor to decide whether joining the study is in the patient's best interests.
Will taking part replace usual intensive care treatments?
No. All patients receive the full standard NHS intensive care treatment, including antibiotics, fluids, and breathing support. The study medicine is given in addition to standard care.
Can a participant leave the study early?
Yes. Patients or their representatives can withdraw from the study at any time. Doing so will not affect the quality of normal NHS care in any way.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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