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Heart failure with reduced ejection fraction – Trials in Disease

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Ongoing Clinical Trials for Heart Failure with Reduced Ejection Fraction

There are currently 12 clinical trials investigating various treatments for heart failure with reduced ejection fraction, a condition where the heart muscle cannot pump blood effectively. These studies are testing medications, cell-based therapies, and treatment strategies aimed at improving heart function, reducing hospitalizations, and enhancing quality of life for patients with this condition.

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Study of Omecamtiv Mecarbil for Treating Patients with Chronic Heart Failure and Severely Reduced Heart Pumping Ability

This study evaluates Omecamtiv Mecarbil, an investigational medication that helps the heart muscle contract more effectively. The goal is to determine whether this medication can reduce serious heart-related events such as hospitalizations and cardiovascular death in patients already receiving standard treatments.

Who can participate: Adults aged 18 to 85 with chronic heart failure who have been receiving treatment for at least three months and are currently taking diuretics. Participants must have an ejection fraction less than 30% if they do not have atrial fibrillation, or less than 25% if they do. They must also have elevated levels of heart-related proteins in their blood and be on stable standard therapies for at least 30 days. Additionally, participants should either be currently hospitalized for heart failure or have had a heart failure event within the past six months.

Who cannot participate: Patients with severe allergic reactions to the study medication, those who had a heart attack in the last 90 days, individuals with uncontrolled high blood pressure, severe kidney or liver disease, and pregnant or breastfeeding women are excluded. Anyone currently participating in another clinical trial or with medical conditions deemed unsafe by study doctors cannot join.

What the study involves: Participants will be randomly assigned to receive either Omecamtiv Mecarbil or a placebo, taken orally as a film-coated tablet. Throughout the study, researchers will monitor heart function, blood pressure, and kidney function through regular check-ups and various assessments. The medication is tested alongside existing heart failure treatments to evaluate its additional benefits.

Study on JTT-861 for Patients with Heart Failure with Reduced Ejection Fraction

This 12-week study examines JTT-861, a new medication designed to improve heart function. Researchers will use echocardiograms and blood tests to monitor changes in heart structure and function throughout the treatment period.

Who can participate: Men and women between 30 and 85 years old who have been diagnosed with heart failure for at least 90 days and are classified as NYHA functional class II or III. Participants must have an ejection fraction of 35% or less and have been on stable heart failure treatment for at least four weeks. They should have elevated levels of NT-pro-BNP (at least 600 pg/mL, or 900 pg/mL if they have atrial fibrillation) and an estimated kidney function between 30 and 90 mL/min/1.73 m². A minimum body weight of 50 kg and BMI of 18.0 kg/m² is required.

Who cannot participate: Patients with conditions other than heart failure with reduced ejection fraction, those outside the specified age range, or individuals who belong to vulnerable populations requiring special protection.

What the study involves: Participants will receive either JTT-861 capsules or a placebo daily for 12 weeks in a double-blind study. Regular assessments will include heart function monitoring, blood tests to measure medication levels, and evaluations of symptoms and quality of life.

Study on Optimizing Treatment for Chronic Heart Failure with Reduced Ejection Fraction Using Nebivolol and a Drug Combination

This research investigates whether the concentration of heart failure medications in the blood is more important than the dosage for improving patient outcomes. The study will track multiple medications over a period of up to 24 months.

Who can participate: Patients over 18 years old with chronic heart failure who are already receiving or starting treatment with the specified medications. Women of childbearing potential must have a negative pregnancy test and agree to use contraception throughout the study.

Who cannot participate: Individuals without chronic heart failure with reduced ejection fraction, those outside the age requirements, or people from vulnerable populations.

What the study involves: Participants will take a combination of medications including nebivolol, carvedilol, bisoprolol fumarate, spironolactone, sacubitril valsartan, and metoprolol succinate orally. Regular monitoring will include blood tests to measure drug concentrations, heart imaging tests, a 6-minute walk test, and quality of life questionnaires to assess the relationship between medication levels and clinical outcomes.

Study on the Effects of Semaglutide and Diet on Physical and Heart Health in Patients with Obesity and Heart Failure

This trial compares weight loss achieved through semaglutide medication versus a calorie-restricted diet to determine which approach better improves physical performance and heart function. The study focuses on measuring peak oxygen uptake as an indicator of heart and lung efficiency.

Who can participate: Adults over 18 years old with a BMI of 30 kg/m² or higher and heart failure with an ejection fraction of 40% or less confirmed by echocardiography or cardiac magnetic resonance. Participants must have been on stable and optimal heart failure treatment for at least four weeks.

Who cannot participate: Patients without both obesity and heart failure with reduced ejection fraction, those outside the age range, or individuals from vulnerable populations such as children or pregnant women.

What the study involves: Participants will receive Wegovy (semaglutide) injections starting at 0.25 mg and gradually increasing to 2.4 mg over 52 weeks. The medication is administered subcutaneously, meaning under the skin. Throughout the study, researchers will monitor physical performance through exercise tests, assess heart function using various imaging techniques, and evaluate quality of life using questionnaires.

Study on the Effects of Vericiguat in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF) Using the CardioMEMS HF System

This study evaluates how Vericiguat affects blood flow in the pulmonary artery, which carries blood from the heart to the lungs. The CardioMEMS HF System, an implanted monitoring device, helps track these changes.

Who can participate: Adults 18 years or older with chronic heart failure and an ejection fraction less than 45% who have had a CardioMEMS device implanted for at least two weeks. Participants must be classified as NYHA functional class II-IV, be on optimal and stable heart failure therapy, and have a systolic blood pressure of at least 100 mmHg. Their diastolic pulmonary artery pressure must be greater than 15 mmHg for more than 8 days in the last 14 days.

Who cannot participate: Patients without heart failure with reduced ejection fraction, those outside the specified age range, or individuals from vulnerable populations.

What the study involves: Participants will be randomly assigned to receive either Vericiguat (2.5 mg, 5 mg, or 10 mg film-coated tablets) or a placebo, taken orally. The study is double-blind, meaning neither participants nor researchers know who receives which treatment. Regular follow-up visits will include monitoring of heart function, blood pressure measurements, and pulmonary artery pressure assessments using the CardioMEMS device.

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 innovative study investigates a cell-based therapy using cardiac atrial stem cells obtained from donor heart tissue. These cells are injected directly into damaged areas of the heart muscle during surgery to evaluate safety and potential benefits for patients with advanced heart failure.

Who can participate: Adults over 18 years old (but not over 65) who have had a documented heart attack caused by narrowed heart arteries and have visible scar tissue on MRI scans. Participants must have an ejection fraction between 25% and 45%, need heart bypass surgery, and have normal blood test results allowing for surgery. Women of childbearing potential must have a negative pregnancy test and use effective birth control for two months before and throughout the study.

Who cannot participate: People younger than 18 or older than 65, those with active cancer or cancer history in the past five years, recent heart attack within 30 days, current participation in other trials, presence of heart tumors, severe kidney or liver disease, active infection, pregnancy or breastfeeding, uncontrolled diabetes, history of severe allergic reactions, mental conditions affecting consent ability, blood disorders increasing bleeding risk, recent major surgery within three months, or uncontrolled heart rhythm problems.

What the study involves: Participants will undergo heart function assessment through various imaging tests and laboratory work. During surgery, they will receive an injection of cardiac atrial stem cells directly into the heart muscle in areas affected by previous heart attack. Follow-up monitoring will include heart function tests, a six-minute walk test, evaluation of heart failure symptoms using the NYHA classification, measurement of damaged heart area size, and monitoring for complications.

Study on Starting Valsartan, Sacubitril, and Empagliflozin for Patients with Heart Failure with Reduced Ejection Fraction

This study compares the safety of two different approaches to starting heart failure medications: beginning both Entresto and Jardiance (or Forxiga) simultaneously versus starting one medication first and adding the second later.

Who can participate: Adults 18 years or older with NYHA class II, III, or IV heart failure symptoms and an ejection fraction of 49% or less. Participants must have kidney function of at least 25 ml/min/1.73m², serum potassium of 5.4 mmol/L or less, and systolic blood pressure of 100 mmHg or higher. They must not have been treated with ARNi or SGLT2i medications in the past month (except if started 5 days before joining) and must be on standard heart failure therapies for at least 30 days. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.

Who cannot participate: Patients with severe allergic reactions to study medications, those who are pregnant or breastfeeding, individuals with severe kidney or liver disease, anyone who had a heart attack in the last three months, those with uncontrolled high blood pressure, individuals with drug or alcohol abuse history in the past year, current participants in other clinical trials, people with serious mental health conditions affecting study compliance, and patients with any other medical condition deemed unsafe by study doctors.

What the study involves: Participants will be randomly assigned to one of two groups. One group starts taking both Entresto (24 mg/26 mg, 49 mg/51 mg, or 97 mg/103 mg twice daily) and Jardiance or Forxiga (10 mg once daily) simultaneously. The other group starts with Jardiance or Forxiga first, with Entresto added between weeks 4 and 12. Regular follow-up visits over six months will monitor blood pressure, kidney function, potassium levels, and any side effects.

Study on the Effects of AZD3427 on Kidney Function in Heart Failure Patients with Kidney Issues

This study examines how AZD3427 affects kidney blood flow in patients who have both heart failure and reduced kidney function. Researchers will use Positron Emission Tomography (PET) imaging to observe changes in kidney function.

Who can participate: Adults over 20 years old with heart failure classified as NYHA I to III for at least 12 months who have been on stable heart failure medication for at least four weeks. Participants must have an ejection fraction of 40% or less and estimated kidney function between 30 and 90 mL/min/1.73 m². A minimum BMI of 18.0 kg/m² and body weight of 50 kg are required. Male participants who have been sterilized must use condoms for three months after dosing. Female participants must be unable to have children, confirmed by being postmenopausal or having had irreversible surgical sterilization.

Who cannot participate: Patients with severe heart failure, serious kidney problems, those outside the specified age range, or individuals from vulnerable populations.

What the study involves: Participants will receive either AZD3427 or a placebo as a solution for injection under controlled conditions. Throughout the study, researchers will monitor vital signs, conduct laboratory tests, and use PET scans to measure changes in kidney function, specifically the volume of the renal cortex with increased perfusion. Blood samples will be collected to understand how the body processes the medication.

Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack

This study evaluates CDR132L, an experimental medication designed to improve heart function after a heart attack. The treatment targets specific molecules involved in heart muscle repair and function.

Who can participate: Men and women 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 an ejection fraction of 45% or less measured by echocardiogram after the heart attack, weigh 120 kg or less, and have NT-proBNP levels between 125 pg/ml and 8000 pg/ml. They must have undergone percutaneous coronary intervention for the heart attack. Patients with a history of previous heart attacks can participate.

Who cannot participate: Patients with recent heart attack or acute left-sided heart failure, those with an ejection fraction below 45% after heart attack who are not receiving standard care, or individuals from vulnerable populations.

What the study involves: Participants will be randomly assigned to receive either a low dose of CDR132L (5 mg/kg), a higher dose (10 mg/kg), or a placebo. The treatment is given through intravenous infusion directly into the bloodstream, with three doses administered 28 days apart. Regular follow-up visits will include heart imaging tests, blood tests, physical exams, and monitoring of heart function to assess the treatment’s impact and safety.

Study on the Safety and Effectiveness of Tovinontrine for Adults with Chronic Heart Failure with Reduced Ejection Fraction

This 12-week study tests Tovinontrine, a phosphodiesterase type 9 inhibitor, to determine the optimal dose and evaluate its effects on heart-related markers in the blood. The study is designed to be double-blind, ensuring unbiased results.

Who can participate: Adults 18 years or older with a medical history of heart failure classified as NYHA functional class II to III for at least six months. Participants must have an ejection fraction of 40% or less confirmed by echocardiogram and NT-proBNP levels of at least 600 pg/mL (or 1000 pg/mL if they have atrial fibrillation or flutter). They must be on stable and optimized heart failure therapy with no new treatments (except diuretics) started in the three months before screening, and treatment should be stable for at least four weeks.

Who cannot participate: Patients without heart failure with reduced ejection fraction, those outside the specified age range, or individuals from vulnerable populations.

What the study involves: Participants will be randomly assigned to receive either Tovinontrine or a placebo in immediate-release tablet form, taken orally twice daily. Regular monitoring throughout the 12-week period will include measurements of NT-proBNP levels, other markers such as urine and plasma cGMP and BNP levels, and quality of life assessments using the Kansas City Cardiomyopathy Questionnaire.

Study on the Safety of Starting Vericiguat at 5 mg in Patients with Chronic Heart Failure with Reduced Ejection Fraction

This two-week study evaluates how well patients tolerate a starting dose of 5 mg of vericiguat. Researchers will monitor whether participants can complete the treatment course without stopping due to side effects or experiencing significant low blood pressure.

Who can participate: Adults with chronic heart failure with an ejection fraction less than 45%, a systolic blood pressure of at least 100 mmHg at the study start, and no changes in heart failure medication doses for a certain period before the study. Participants should have no planned medical procedures two weeks before or during the study and may be with or without a recent worsening heart failure event.

Who cannot participate: Patients without chronic heart failure with reduced ejection fraction, those outside the specified age range, or individuals from vulnerable populations.

What the study involves: Participants will take vericiguat as a 5 mg film-coated tablet orally once daily for two weeks. Close monitoring throughout this period will track the ability to tolerate the medication, with particular attention to blood pressure readings and any side effects or adverse events experienced between the first and second visits.

Summary

These 12 clinical trials represent diverse approaches to treating heart failure with reduced ejection fraction, ranging from traditional pharmaceutical interventions to innovative cell-based therapies. The research spans multiple European countries, with notable concentration of trials in Germany, Poland, Spain, and Italy. Several medications, particularly vericiguat, appear in multiple studies across different phases and patient populations, indicating significant research interest in this compound.

The trials encompass various treatment strategies, including cardiac myosin activators, phosphodiesterase inhibitors, GLP-1 receptor agonists for patients with obesity, and combination therapies optimizing existing medications. One particularly innovative approach involves cardiac atrial stem cell therapy, representing a shift toward regenerative medicine for heart failure treatment.

Many studies focus on patients with severely reduced ejection fraction (typically 40-45% or less) who are already receiving standard guideline-directed medical therapy, aiming to provide additional therapeutic benefits beyond current treatment approaches. Several trials specifically target patients who have experienced recent heart failure events or hospitalizations, addressing a critical period for intervention.

The research reflects a comprehensive effort to address different aspects of heart failure management, from improving heart pumping function and reducing hospitalizations to enhancing quality of life and physical performance. Patient safety remains a paramount concern across all trials, with careful monitoring protocols and clearly defined inclusion and exclusion criteria to protect participants while gathering valuable scientific data.

Ongoing Clinical Trials on Heart failure with reduced ejection fraction

  • Study on Vericiguat for Adults with Chronic Heart Failure with Reduced Ejection Fraction

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Denmark France Germany Greece +6

  • Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Greece Hungary The Netherlands Poland +1

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