In short
Two clinical trials are currently investigating new treatments for chronic left ventricular failure. One trial is testing the medication Vericiguat in children and teenagers across 14 European countries, while the other is evaluating cardiac stem cell therapy for adults in Belgium who have experienced a heart attack. Both studies aim to improve heart function in patients whose hearts are unable to pump blood effectively.
Clinical trial locations
- Belgium
- Croatia
- Denmark
- Finland
- France
- Germany
- Hungary
- Ireland
- Italy
- Netherlands
- Poland
- Portugal
- Spain
- Sweden
Study on Vericiguat for Children with Heart Failure Due to Left Ventricular Systolic Dysfunction
This trial is testing a medication called Vericiguat in children and teenagers with heart failure caused by problems with the left side of the heart not pumping properly. Vericiguat is taken by mouth as either a tablet or liquid suspension and works by helping blood vessels relax and widen, making it easier for the heart to pump blood throughout the body.
Who can participate:
- Children and teenagers aged more than 28 days but less than 18 years
- Those with a history of chronic heart failure due to the left ventricle not pumping well
- Patients with a heart pumping function (left ventricular ejection fraction) of less than 45%
- Those currently receiving stable medical treatment for heart failure
- Patients with both sides of the heart working, with a normal left side
- Female participants must not be pregnant or breastfeeding and must use effective birth control
Who cannot participate:
- Patients with heart failure caused by systemic left ventricular systolic dysfunction
- Those outside the specified age range
- Vulnerable populations who may be unable to give proper consent
What the study involves: Participants will be randomly assigned to receive either Vericiguat or a placebo (an inactive substance). Neither the participants nor the study team will know which treatment is being given. The medication is taken once daily at doses of 2.5 mg, 5 mg, or 10 mg, depending on individual needs. The treatment is expected to last up to 52 weeks.
Throughout the study, participants will have regular check-ups including physical examinations and blood tests. The main goal is to measure changes in a blood marker called NT-proBNP, which indicates how well the heart is working. This will be measured from the start of the study to week 16. The study team will also monitor for any side effects and serious events such as hospitalization due to heart problems.
Study of cardiac atrial stem cells injected into heart muscle for treating advanced heart failure in patients with prior heart attack and reduced heart function
This study is investigating a novel treatment involving cardiac atrial stem cells for adults with advanced heart failure who have previously had a heart attack. The stem cells are obtained from donor heart tissue and are injected directly into the damaged heart muscle during surgery.
Who can participate:
- Adults over 18 years old but not older than 65 years
- Those who have had a documented heart attack caused by narrowed heart arteries
- Patients with heart muscle that doesn't work properly, visible on imaging tests
- Those with scar tissue in the heart visible on MRI scan
- Patients with a heart pumping function (ejection fraction) between 25% and 45%
- Those who need heart bypass surgery in the area affected by the heart attack
- Patients with normal blood test results that allow for surgery
- Women who can become pregnant must have a negative pregnancy test and use effective birth control for 2 months before and throughout the study
- Must be able to understand and sign the informed consent form and attend all follow-up visits
Who cannot participate:
- Those under 18 or over 65 years old
- Patients with active cancer or history of cancer in the past 5 years
- Those who had a heart attack within the last 30 days
- People currently participating in other clinical trials
- Patients with heart tumors or history of heart tumors
- Those with severe kidney or liver disease
- People with active infection or fever
- Pregnant or breastfeeding women
- Patients with uncontrolled diabetes
- Those with history of severe allergic reactions
- People with mental conditions affecting their ability to provide consent
- Patients with blood disorders increasing bleeding risk
- Those who had major surgery within the last 3 months
- People with uncontrolled heart rhythm problems
- Those with substance abuse or alcohol dependency
What the study involves: Before the procedure, patients undergo thorough evaluation including heart imaging tests such as echocardiogram and MRI to confirm their heart condition and the presence of scar tissue. During surgery, cardiac atrial stem cells from a donor are injected directly into the damaged areas of the heart muscle. The procedure may be performed along with heart bypass surgery if needed.
After treatment, patients are closely monitored through regular follow-up visits. The medical team performs various tests to check heart function and conducts a six-minute walk test to assess exercise capacity. Heart failure symptoms are evaluated, and the size of the damaged heart area is measured. The study runs from June 2025 through December 2026, and participants must attend all scheduled follow-up visits during this period.
Summary
Currently, two clinical trials are actively investigating treatments for chronic left ventricular failure, representing different approaches for different age groups. The pediatric trial testing Vericiguat is notably widespread, taking place across 14 European countries including Belgium, Netherlands, Spain, Denmark, Italy, France, Germany, Finland, Hungary, Sweden, Ireland, Croatia, Portugal, and Poland. This broad geographic distribution suggests a significant effort to recruit young patients for this medication study.
In contrast, the stem cell therapy trial is limited to Belgium and focuses exclusively on adults aged 18 to 65 who have experienced a previous heart attack. This trial represents an innovative approach using regenerative medicine to treat damaged heart tissue, though it is still in early-phase testing.
Both studies target patients whose hearts have reduced pumping function, but they differ significantly in their treatment approaches. The Vericiguat study uses an oral medication to help blood vessels relax, while the stem cell study involves a surgical procedure to inject specialized cells directly into damaged heart muscle. The different methodologies reflect the range of research being conducted to find effective treatments for this serious condition affecting the heart's ability to pump blood effectively.
