Ongoing Clinical Trials for Congestive Heart Failure
Currently, there are 7 clinical trials investigating new treatments for congestive heart failure, a condition where the heart cannot pump blood effectively. These studies are taking place across Europe, testing various medications and therapies including peritoneal ultrafiltration, combination diuretic treatments, heart stem cell injections, and investigational drugs aimed at improving heart function and quality of life for patients.
Clinical trial locations
- Belgium
- Czechia
- Germany
- Greece
- Hungary
- Italy
- Study on Peritoneal Ultrafiltration with PolyCore for Patients with Congestive Heart Failure Using Levocarnitine and Drug Combination
- Study on the Effects of Metolazone, Acetazolamide, and a Drug Combination for Patients with Chronic Heart Failure
- Study on Vitamin D and Oral Iron for Patients with Chronic Heart Failure and Iron Deficiency
- Netherlands
- Poland
- Spain
Study on Peritoneal Ultrafiltration with PolyCore for Patients with Congestive Heart Failure Using Levocarnitine and Drug Combination
This Italian study is investigating a treatment approach called peritoneal ultrafiltration using a solution named PolyCore. The solution contains several active ingredients including levocarnitine, magnesium chloride, sodium chloride, calcium chloride, lactic acid, xylitol, and polydextrose, which work together to help manage fluid levels in the body.
Who can participate: Adult patients with severe heart failure (NYHA Class III-IV) and a left ventricular ejection fraction of 60% or less. Participants must have ongoing right ventricular failure, enlarged cava vein, and decreased kidney function with specific measurements. Blood tests must show elevated NT pro-BNP or BNP levels, and patients should have experienced at least one episode requiring high-dose intravenous diuretics in the past six months.
Who cannot participate: Patients without congestive heart failure or those outside the specified health parameters cannot join this study.
Study focus: The trial aims to evaluate whether peritoneal ultrafiltration with PolyCore can impact health outcomes in patients with cardio-renal syndrome, potentially reducing the risk of hospitalization or worsening of their condition. Throughout the study, participants will undergo regular assessments including walking tests, quality of life evaluations, and blood tests to measure heart function markers.
Study on the Effects of Metolazone, Acetazolamide, and a Drug Combination for Patients with Chronic Heart Failure
This study, also conducted in Italy, compares two treatment strategies for chronic heart failure. The trial tests whether adding acetazolamide and metolazone to standard diuretic therapy can provide better results than standard treatment alone.
Who can participate: Adults aged 18 to 80 years with chronic heart failure who have been discharged from hospital after acute heart failure treatment. Participants must have experienced at least two episodes of worsening heart failure in the past year and be currently taking loop diuretics at doses equivalent to or higher than 40 mg of furosemide.
Who cannot participate: Patients without chronic heart failure or those outside the specified age range are excluded.
Study focus: The three-month study evaluates whether the combination therapy can improve exercise capacity, breathing, and fluid balance better than standard treatment. The medications are taken as tablets by mouth. Researchers will monitor how often patients need hospitalization due to heart failure and track overall improvements in their condition.
Investigational drugs: The study uses loop diuretics and potassium-sparing diuretics as standard treatment, while the experimental group also receives acetazolamide (250 mg tablets) and metolazone (5 mg or 10 mg tablets with flexible dosing).
Study on the Effects of Sacubitril/Valsartan and Ramipril on Heart Function in Patients with Ischemic Heart Failure with Mid-Range Ejection Fraction
This Polish trial compares two medications—sacubitril/valsartan and ramipril—in patients with heart failure with moderately reduced ejection fraction (HFmrEF), a condition affecting the heart’s ability to pump blood effectively.
Who can participate: Adults aged 18 or older with NYHA class II to IV heart failure symptoms due to ischemic causes (reduced blood flow to the heart). Participants must have a left ventricular ejection fraction between 40% and 49%, elevated NT-proBNP levels (at least 125 pg/ml in normal rhythm or 350 pg/ml with irregular rhythm), and be on optimal treatment with ACE inhibitors or ARBs and beta-blockers.
Who cannot participate: Patients with severe heart conditions other than HFmrEF, recent heart attacks, severe kidney or liver disease, allergies to study medications, pregnancy or breastfeeding, inability to undergo MRI scans, or participation in other clinical trials are excluded.
Study focus: The 12-month trial uses magnetic resonance imaging to monitor changes in the heart’s left ventricle size and function. Researchers will also track hospitalizations related to heart failure and overall cardiovascular events. Both medications are taken orally according to the study protocol.
Study on Vitamin D and Oral Iron for Patients with Chronic Heart Failure and Iron Deficiency
This Italian study evaluates whether combining vitamin D with an oral iron supplement (sucrosomial iron) can be as effective as intravenous iron treatment (ferric carboxymaltose) in improving heart failure symptoms.
Who can participate: Adults aged 18 or older with stable chronic heart failure (NYHA class II-III) who have not been hospitalized for heart failure in the past three weeks. Participants must have a left ventricular ejection fraction of 45% or less, elevated BNP or NT-proBNP levels, signs of iron deficiency (ferritin less than 100 ng/mL or TSAT less than 20%), vitamin D levels below 50 nmol/L, and be able to complete a 6-Minute Walking Test.
Who cannot participate: Patients without chronic heart failure or iron deficiency, or those outside the specified age range cannot participate.
Study focus: The 24-week study monitors improvements in walking distance, quality of life, and heart function. Participants receive either the vitamin D and oral iron combination or intravenous ferric carboxymaltose. Regular assessments include questionnaires, echocardiograms, and blood tests to evaluate the treatment’s effectiveness in managing both conditions.
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 Belgian study investigates whether injecting cardiac atrial stem cells directly into the heart muscle can help improve heart function in patients who have experienced a heart attack and have reduced heart function.
Who can participate: Adults over 18 years old (up to 65 years) with documented heart attack caused by narrowed heart arteries. Participants must have non-functioning heart muscle areas visible on imaging tests, scar tissue visible on MRI, heart pumping function (ejection fraction) between 25% and 45%, need heart bypass surgery in the affected area, normal blood test results allowing surgery, and ability to understand and follow all study procedures. Women who can become pregnant must have a negative pregnancy test and use effective birth control throughout the study.
Who cannot participate: People with active cancer or cancer history within the past 5 years, recent heart attack (within 30 days), participation in other trials, heart tumors, severe kidney or liver disease, active infection, pregnancy or breastfeeding, uncontrolled diabetes, history of severe allergic reactions, mental conditions affecting consent, bleeding disorders, recent major surgery (within 3 months), or uncontrolled heart rhythm problems are excluded.
Study focus: The cardiac atrial stem cells, obtained from donor heart tissue, are injected directly into damaged areas of the heart during surgery. The study monitors heart function through regular tests including echocardiograms, MRI scans, walking tests, and evaluations of heart failure symptoms. The trial runs from June 2025 through December 2026, focusing primarily on safety and potential improvements in heart function.
Study on the Effects of Dobutamine and Levosimendan in Patients with Heart Failure and Reduced Left Ventricular Function
This Spanish study compares two medications—dobutamine and levosimendan—in treating heart failure patients with reduced left ventricular pumping ability.
Who can participate: Adults over 18 years old with left ventricular ejection fraction less than 35% (confirmed by echocardiogram within the past 6 months), classified as NYHA functional class III or higher despite optimal treatment and diuretics. Participants must have had recent hospitalization or outpatient treatment for worsening heart failure requiring diuretics in the last six months, leading to the need for a CardioMEMS monitoring device.
Who cannot participate: Patients without heart failure with reduced ejection fraction, those outside the specified age range, or those in vulnerable populations are excluded.
Study focus: The trial compares how these intravenously administered medications affect lung blood vessel pressure and the amount of blood the heart pumps. Throughout the study, participants undergo regular monitoring of heart function, blood pressure, quality of life assessments, and physical tests including a 6-minute walk test to evaluate their physical capabilities and overall response to treatment.
Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack
This multi-country study (Hungary, Netherlands, Spain, Greece, Germany, Czechia, and Poland) investigates an experimental medication called CDR132L in patients who have weakened heart function after a heart attack.
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. Participants must have a left ventricular ejection fraction of 45% or less (measured by echocardiogram after the heart attack), body weight of 120 kg or less, NT-proBNP levels between 125 and 8000 pg/ml, and have undergone percutaneous coronary intervention for their heart attack. Patients with previous heart attack history can also participate.
Who cannot participate: Patients with recent heart attack or acute left-sided heart failure, those not receiving standard care treatment, or those who are part of vulnerable populations are excluded.
Study focus: Participants are randomly assigned to receive either a low dose of CDR132L (5 mg/kg), a higher dose (10 mg/kg), or a placebo. The medication is delivered through intravenous infusion in three doses, each given 28 days apart. The study monitors changes in heart function through regular physical exams, heart imaging tests, and blood tests to evaluate both effectiveness and safety of CDR132L in improving heart function and reducing symptoms after a heart attack.
Summary
These seven clinical trials represent diverse approaches to treating congestive heart failure across Europe. Italy hosts the most trials with three studies focusing on fluid management strategies, including peritoneal ultrafiltration, combination diuretic therapy, and vitamin D with oral iron supplementation. A notable multi-country trial involving seven nations is investigating the experimental drug CDR132L for post-heart attack heart failure.
The studies employ various treatment strategies ranging from innovative fluid removal techniques and combination drug therapies to regenerative medicine approaches using stem cells. Several trials focus on comparing existing medications to determine optimal treatment strategies, while others explore entirely new therapeutic approaches. Treatment durations vary from three months to over two years, with most studies incorporating comprehensive monitoring including imaging tests, walking assessments, and quality of life evaluations.
The geographic concentration of trials in Italy and the broad European collaboration on the CDR132L study suggest both national research priorities and international cooperation in advancing heart failure treatment. These trials address different aspects of heart failure management, from acute symptom relief to long-term structural improvements in heart function, offering hope for improved treatment options for patients living with this challenging condition.
