Clinical Trials for Cardiogenic Shock: Current Research and Opportunities
Cardiogenic shock is a life-threatening condition where the heart suddenly cannot pump enough blood to meet the body’s needs. Currently, 9 clinical trials are investigating new treatments and approaches to improve outcomes for patients experiencing this severe heart condition. These studies are testing various medications and treatment strategies across multiple countries in Europe.
Clinical trial locations
- Austria
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Spain
Study on Cangrelor and Bivalirudin for Patients with Heart Attack-Related Cardiogenic Shock or Cardiac Arrest on VA-ECMO Support
This trial is testing a combination of two blood-thinning medications, cangrelor and bivalirudin, in patients who have experienced a severe heart attack leading to cardiogenic shock or cardiac arrest and require VA-ECMO support. VA-ECMO is a special machine that helps the heart and lungs function when they cannot work properly on their own.
Who can participate: Adults aged 18 or older who have acute coronary syndrome that has led to cardiogenic shock or cardiac arrest, are undergoing a procedure called PCI to open blocked heart arteries, need VA-ECMO support, and have received aspirin intravenously before reaching the hospital or have not taken any blood clot prevention medications.
Who cannot participate: Patients not undergoing VA-ECMO treatment for heart-related issues, those not receiving PCI, those not being treated with bivalirudin and cangrelor, and individuals considered part of vulnerable populations.
Treatment approach: The medications cangrelor and bivalirudin are given through intravenous infusion. Cangrelor dosing starts at a low level and may be adjusted based on blood tests that measure how well blood is clotting. The goal is to prevent dangerous blood clots while minimizing bleeding risks during and after the heart procedure.
What the study measures: Researchers will track the occurrence of blood clots and bleeding events throughout the treatment period, with particular attention to major bleeding complications.
Study on Esmolol Hydrochloride, Dobutamine, and Milrinone for Patients with Cardiogenic Shock on V-A ECMO Support
This study compares two different approaches to managing heart function in patients on V-A ECMO support: continuing to stimulate the heart with medications like dobutamine and milrinone versus slowing the heart rate with esmolol hydrochloride.
Who can participate: Adults 18 years or older who have been on V-A ECMO support for less than 16 hours due to severe heart failure, are receiving dobutamine at a rate of at least 2 micrograms per kilogram per minute, are receiving norepinephrine at a rate of 0.4 micrograms per kilogram per minute or less, and have a heart rate of 80 beats per minute or more.
Who cannot participate: The trial specifically excludes patients who do not meet the inclusion criteria related to ECMO support timing and medication requirements.
Treatment approach: Participants are randomly assigned to either continue beta receptor stimulation with current medications or receive beta receptor inhibition with intravenously administered medication. The study focuses on monitoring heart rate changes and various heart function measurements over 48 hours.
What the study measures: The primary focus is on heart rate changes measured 24 hours after treatment begins. Additional assessments include heart function measurements, blood pressure monitoring, and biomarkers related to heart stress and injury.
Study on the Early Use of Levosimendan Compared to Placebo for Patients with Cardiogenic Shock
This French trial investigates whether early use of levosimendan, a medication that helps the heart pump more effectively, can improve outcomes for patients experiencing cardiogenic shock when added to standard treatment.
Who can participate: Adults aged 18 to 65 years with cardiogenic shock, adequate blood vessel fluid levels, receiving norepinephrine or dobutamine for at least 3 hours but less than 24 hours to maintain blood pressure, showing signs of inadequate blood flow to tissues such as elevated lactate levels or reduced urine output, and affiliated with a social security plan.
Who cannot participate: Patients not experiencing cardiogenic shock, those under 18 or over 65 years old, and individuals unable to give informed consent or considered part of vulnerable populations.
Treatment approach: Participants receive either levosimendan or a placebo through intravenous infusion, in addition to their standard care. The medication is designed to enhance the heart’s ability to contract and pump blood more effectively.
What the study measures: The main outcomes include 30-day mortality rates and the need for additional life support such as extracorporeal life support or dialysis. Follow-up assessments continue at various intervals up to 12 months, evaluating overall health, cardiovascular events, hospital stay duration, and quality of life.
Study on the Effects of Empagliflozin for Patients with Cardiogenic Shock
This study examines whether empagliflozin, a medication typically used for diabetes that works as a sodium glucose cotransporter 2 inhibitor, can improve outcomes when added early to standard treatment for patients with cardiogenic shock.
Who can participate: Adults 18 years or older hospitalized in a critical cardiac care unit or intensive care unit for cardiogenic shock, who have been receiving catecholamine medications for more than 12 hours, and are affiliated with a social security scheme.
Who cannot participate: The trial specifically focuses on patients meeting the inclusion criteria and excludes those not experiencing cardiogenic shock.
Treatment approach: Participants are randomly assigned to receive either standard management alone or standard management plus empagliflozin, administered orally as 10 mg tablets. The treatment period lasts 12 weeks.
What the study measures: Researchers evaluate survival rates, rehospitalization for heart failure, heart function through measurements of left ventricular ejection fraction, kidney and liver function, weight changes, and levels of NT-proBNP, a marker of heart stress.
Study on the Effects of Levosimendan for Patients with Cardiogenic Shock Being Weaned from ECMO
This Austrian trial focuses on patients transitioning off ECMO support and tests whether levosimendan can improve heart function and blood flow during this critical weaning period.
Who can participate: Adults 18 years or older currently receiving ECMO treatment for cardiogenic shock or refractory cardiac arrest, where the heart has stopped beating and is not responding to standard treatments.
Who cannot participate: Patients not within the specified age range, those not meeting the clinical trial group criteria, and individuals considered part of vulnerable populations.
Treatment approach: Levosimendan is administered as a solution for infusion at a dosage of 2.5 mg/ml. The medication works by increasing the strength of the heart’s contractions and improving blood flow, making it easier for the heart to function independently as ECMO support is reduced.
What the study measures: The primary outcome is changes in heart function measured through Doppler echocardiography from baseline to 72 hours after starting ECMO or before support is stopped. Secondary outcomes include blood pressure changes, successful ECMO weaning, mortality rates, urine output, and oxygen saturation levels.
Study Comparing Norepinephrine and Dobutamine for Patients with Cardiogenic Shock
This Italian study compares the effectiveness of two medication approaches: norepinephrine alone versus a combination of norepinephrine and dobutamine, in managing patients with cardiogenic shock and low blood pressure.
Who can participate: Adults over 18 years old with cardiogenic shock, systolic blood pressure below 90 mmHg or mean arterial pressure below 60 mmHg for at least 30 consecutive minutes, requiring medications to maintain blood pressure, enrolled within 3 hours of the acute event, and having a SOFA score less than 2.
Who cannot participate: The trial specifically focuses on patients with cardiogenic shock meeting the inclusion criteria.
Treatment approach: Participants receive either norepinephrine alone or dobutamine plus norepinephrine through intravenous infusion. Norepinephrine helps increase blood pressure by narrowing blood vessels, while dobutamine stimulates the heart to pump more effectively.
What the study measures: The main focus is on changes in blood lactate levels over 72 hours, which indicate how well the body is responding to treatment. Additional outcomes include survival rates, need for additional medical support devices, and changes in the SOFA score, which assesses organ function.
Study on Isoflurane, Propofol, and Dobutamine Hydrochloride for Sedation in Adults with Severe Cardiogenic Shock on ECMO
This French trial investigates the use of inhaled isoflurane for sedation in patients with severe cardiogenic shock who are on VA-ECMO support and mechanical ventilation.
Who can participate: Adult patients with severe cardiogenic shock on VA-ECMO support for less than 24 hours, on invasive mechanical ventilation for less than 48 hours, receiving propofol and/or midazolam sedation, expected to need ventilation and sedation for at least 24 hours with a Richmond agitation scale target of -1 to -4, and registered with social security.
Who cannot participate: Patients on VA-ECMO for more than 24 hours, those under 18 years old, patients not experiencing severe cardiogenic shock, those unable to use the inhaled medication, and individuals from vulnerable populations.
Treatment approach: Isoflurane is administered as an inhaled gas through a device that conserves anesthetic. The medication helps patients relax and stay calm while on life support by affecting brain neurotransmitters that maintain sedation.
What the study measures: The primary outcome combines survival and the number of days patients are free from mechanical ventilation within 28 days of starting ECMO. Secondary outcomes include overall survival, days free from ECMO, days free from intensive care, and monitoring for any adverse effects.
Study on Istaroxime for Patients with Cardiogenic Shock Stage C
This multi-country trial spanning Poland, Czechia, and Italy evaluates istaroxime, a cardiotonic agent designed to improve heart function in patients with SCAI Stage C cardiogenic shock caused by acute decompensated heart failure.
Who can participate: Adults aged 18 to 85 years with SCAI Stage C cardiogenic shock, admitted to the ICU within 36 hours with signs of lung fluid accumulation and specific blood test results, having a history of left ventricular ejection fraction of 40% or less, experiencing ongoing low blood pressure between 70 and 90 mmHg with signs of poor blood flow to organs, and with echocardiogram confirmation of reduced heart function.
Who cannot participate: Patients who have received digoxin since hospital admission or are on mechanical support for the heart, lungs, or kidneys.
Treatment approach: Istaroxime is administered intravenously as a powder mixed into solution. The medication works by enhancing the heart’s ability to contract and helping the heart muscle relax, which improves blood flow and increases blood pressure.
What the study measures: The primary outcome is the change in systolic blood pressure from the start of infusion to 6 hours. Additional assessments occur at 24 and 48 hours, evaluating overall response to treatment, need for additional heart-supporting medications, and days alive and out of hospital within 30 days.
Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack
This international trial across seven European countries tests CDR132L, an experimental medication designed to improve heart function in patients who have experienced a heart attack and have weakened heart pumping ability.
Who can participate: Adults aged 30 to 80 years who have experienced a spontaneous acute heart attack and can be enrolled within 14 days of diagnosis, have a left ventricular ejection fraction of 45% or less measured by echocardiogram after the heart attack, weigh 120 kg or less, have NT-proBNP levels between 125 and 8000 pg/ml, and underwent percutaneous coronary intervention for the heart attack.
Who cannot participate: Patients with recent heart attacks or acute left-sided heart failure, those with LVEF of 45% or less after a heart attack who are not receiving standard care, and individuals from vulnerable populations.
Treatment approach: CDR132L is administered through intravenous infusion in three doses, each given 28 days apart. Participants are randomly assigned to receive either a low dose (5 mg/kg), a higher dose (10 mg/kg), or a placebo. The medication targets specific molecules involved in heart muscle repair and function.
What the study measures: Researchers monitor changes in heart function through imaging tests and blood tests over time. Follow-up assessments track cardiovascular events, need for medical interventions, hospital stay duration, and overall health improvements up to 12 months after treatment begins.
Summary
The current landscape of clinical trials for cardiogenic shock reflects a diverse approach to addressing this critical condition. France leads with three ongoing trials, followed by Italy with three trials, and multiple other European countries hosting one to two trials each. This geographic distribution demonstrates a strong European commitment to advancing treatment options.
Several medications appear prominently across these studies. Levosimendan is being investigated in two separate trials, examining its potential both during ECMO weaning and as an early intervention. The research also explores various medication classes, from traditional cardiovascular drugs like norepinephrine and dobutamine to newer approaches such as empagliflozin, traditionally used for diabetes, and experimental medications like CDR132L and istaroxime.
A notable focus exists on patients requiring ECMO support, with multiple trials specifically targeting this population. These studies address critical questions about medication management, sedation strategies, and blood clot prevention in patients needing advanced mechanical circulatory support.
The trials vary in their approach, from comparing standard medications to testing novel experimental compounds, reflecting both refinement of existing practices and pursuit of innovative treatment options. This comprehensive research effort aims to improve survival rates, reduce complications, and enhance quality of life for patients experiencing this severe cardiac emergency.
