Ongoing Clinical Trials for Low Cardiac Output Syndrome
Two clinical trials are currently investigating treatments for low cardiac output syndrome, a serious condition where the heart cannot pump enough blood to meet the body’s needs. These studies are testing innovative approaches to prevent or treat this condition, particularly in patients undergoing heart surgery or recovering from heart attacks. The trials are taking place across multiple European countries.
Clinical trial locations
- Czechia
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Spain
Study on the Use of Landiolol Hydrochloride and Sodium Chloride for Patients Undergoing Mitral Valve Surgery to Prevent Low-Cardiac Output Syndrome
This trial is being conducted in Italy and focuses on preventing low cardiac output syndrome in patients undergoing mitral valve surgery. The mitral valve is one of the heart’s four valves, and when it needs repair or replacement, patients are at risk of developing complications where the heart cannot pump enough blood after surgery.
Who can participate: This study is looking for adults over 18 years of age who are scheduled for planned (not emergency) mitral valve repair or replacement surgery. The surgery must involve a cardiopulmonary bypass machine, which temporarily takes over the function of the heart and lungs during the procedure. Participants must have specific heart measurements showing that their left ventricle is enlarged or not pumping as efficiently as it should, including an ejection fraction of less than 60%. All participants must sign an informed consent form agreeing to participate.
Who cannot participate: The trial excludes patients who do not meet the specific heart measurement criteria or who cannot undergo the required type of surgical approach.
What the trial aims to discover: The primary goal is to determine whether landiolol hydrochloride, a beta-blocker medication, can reduce the occurrence of low cardiac output syndrome after mitral valve surgery. The medication works by slowing down the heart rate and reducing the heart’s workload, potentially protecting the heart during and after surgery. Researchers will monitor participants’ heart function and recovery to assess whether the treatment is effective.
Investigational treatment: The trial tests landiolol, administered through an intravenous infusion during surgery. This medication is given as an addition to cardioplegia, a technique used to protect the heart during surgery. Participants will be randomly assigned to receive either landiolol or a placebo, and neither the participants nor researchers will know who receives which treatment until the study is complete.
Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack
This international trial is taking place across seven European countries: Hungary, the Netherlands, Spain, Greece, Germany, Czechia, and Poland. It focuses on patients who have experienced a heart attack and are left with reduced heart function, which can lead to complications including low cardiac output syndrome.
Who can participate: The study is recruiting adults between 30 and 80 years old who have recently experienced a heart attack, specifically within the past 14 days. Participants must have a left ventricular ejection fraction of 45% or less, meaning their heart is not pumping blood as effectively as it should. They must weigh 120 kg or less and have specific blood test results showing their NT-proBNP levels are between 125 and 8000 pg/ml. This blood test helps doctors assess how well the heart is functioning. Participants must have undergone a procedure called percutaneous coronary intervention to open blocked heart arteries during their heart attack treatment. People with a history of previous heart attacks can still participate.
Who cannot participate: Patients currently experiencing acute heart failure on the left side of the heart or those not receiving standard care treatment cannot join the study. Vulnerable populations with certain health or social circumstances are also excluded.
What the trial aims to discover: Researchers want to determine whether CDR132L can improve heart function in patients who have weakened heart muscle after a heart attack. The study will track changes in how well the heart pumps blood and monitor overall health improvements. The trial will also carefully assess the safety of the medication and track any side effects or health changes participants experience.
Investigational treatment: The experimental medication CDR132L is given through an intravenous infusion directly into the bloodstream. Participants will receive three doses, each given 28 days apart. Two groups will receive different dose levels of CDR132L (either 5 mg/kg or 10 mg/kg of body weight), while a third group will receive a placebo. The medication targets specific molecules in the body that affect heart muscle repair and function, with the goal of helping the heart pump blood more effectively when added to standard heart failure treatments.
Summary
Currently, two clinical trials are actively investigating approaches to address low cardiac output syndrome through different strategies. One trial focuses on prevention during surgery, while the other aims to improve heart function after a heart attack.
The trials are geographically concentrated in Europe, with the CDR132L study having a broader reach across seven countries, while the landiolol study is limited to Italy. This geographic distribution may reflect different research priorities and healthcare infrastructure across European nations.
Both studies test innovative medications that work through different mechanisms: landiolol is a beta-blocker with established use in other contexts, while CDR132L represents a novel experimental approach targeting heart muscle repair. The trials employ rigorous double-blind, placebo-controlled designs to ensure reliable results.
Patients interested in participating should discuss these options with their healthcare providers to determine eligibility and whether participation aligns with their individual circumstances and treatment needs.