A Multicenter, Randomized, Placebo-Controlled, Parallel Group Trial on the Safety and Efficacy of Istaroxime for Cardiogenic Shock SCAI Stage C (SEISMiC-C)
This research study, called SEISMiC-C, is looking into a new medicine called Istaroxime. It's for adults who have cardiogenic shock, a serious condition where the heart can't pump enough blood for the body's needs. The study aims to find out if Istaroxime is safe and effective at improving blood pressure. Half the participants will receive Istaroxime, and the other half will receive a dummy medicine called a placebo – neither the patient nor the doctor will know who gets what. This is a Phase II study, meaning it's an earlier stage designed to see if the treatment shows promise before larger studies are conducted. The main thing researchers will measure is how well Istaroxime helps keep blood pressure steady in the first few hours after treatment.
At a glance
What is this study about?
This study is called SEISMiC-C, and it's looking into a new medicine called Istaroxime for a serious heart problem known as cardiogenic shock. Cardiogenic shock happens when your heart suddenly can't pump enough blood to meet your body's needs. This can be life-threatening, so finding effective treatments is very important.
Researchers want to see if Istaroxime can help improve blood pressure and support the heart's function in people with this condition. They will compare it to a 'placebo,' which looks just like the real medicine but contains no active drug. This helps them understand if any improvements are truly due to Istaroxime or just other factors.
This is a 'Phase II' study. This means it's one of the first studies involving people, and its main goal is to figure out if Istaroxime is safe, what dosage might be best, and if it shows enough promise to be tested in even larger studies later on. The study will mainly focus on how Istaroxime affects your blood pressure in the first few hours after you receive it.
Key takeaways
- This study is testing a new medicine for serious heart failure called cardiogenic shock.
- It aims to see if the new medicine, Istaroxime, is safe and helps improve blood pressure.
- Participants will receive either Istaroxime or a dummy medicine (placebo).
- It's an early-stage study to gather important information before larger trials.
- Your blood pressure and heart function will be closely monitored if you take part.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Because cardiogenic shock can affect people differently, the detailed study rules (called eligibility criteria) will be carefully checked by the study doctor to make sure it's safe and appropriate for you to participate. These rules might include specific aspects of your heart condition, your overall health, and any other medicines you are taking.
The study team will review all your medical information to confirm if you meet all the necessary requirements to take part. It's important that you discuss your full medical history with them.
- Are you 18 years old or older?
- Do you have a diagnosis of cardiogenic shock?
- Are you able to manage study visits and assessments?
- Are you willing to potentially receive either the study drug or a placebo?
- Are you open to having your blood pressure and heart watched closely?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive either the study medicine, Istaroxime, or a placebo (dummy medicine) through a drip. Neither you nor your doctors will know which one you are getting. Your blood pressure will be closely monitored, especially during the first six hours after starting the treatment.
Over the next few days, the study team will continue to monitor how your heart is working and how you are feeling. They will check your vital signs, take blood tests, and assess whether you need any other medications or support for your heart. Some of these measurements will help them calculate a 'Vasoactive-Inotropic Score' to see how your heart's support needs are changing. You will be followed up for a total of 30 days from when you start the study to see how you are recovering and if you've needed to return to the hospital.
Potential risks and benefits
Locations (3)
- —Poland
- —Czechia
- —Italy
Common questions
What is cardiogenic shock?
Cardiogenic shock is a severe condition where your heart suddenly can't pump enough blood to meet your body's needs, often leading to very low blood pressure.
What is Istaroxime?
Istaroxime is the new medicine being tested in this study. Researchers want to see if it helps improve blood pressure and heart function in cardiogenic shock.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real thing but has no active drug. It helps researchers fairly compare the new medicine's effects.
What is the main goal of this study?
The main goal is to see if Istaroxime is safe and can improve blood pressure in patients with cardiogenic shock during the first few hours of treatment.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and your medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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