Clinical Trials for Chronic Heart Failure
This article provides information about ongoing clinical trials for chronic heart failure, a condition where the heart cannot pump blood effectively to meet the body’s needs. Currently, there are 11 active trials testing various treatments including iron supplements, medications to improve heart function, and innovative cell-based therapies. These studies are being conducted across multiple European countries and aim to improve treatment options for people living with this condition.
Clinical trial locations
- Belgium
- Bulgaria
- Croatia
- Czechia
- Denmark
- Study on Hydralazine, Isosorbide Dinitrate, and Metformin for Patients with Chronic Heart Failure and Reduced Heart Function
- Study on the Effects of AZD5462 for Patients with Stable Chronic Heart Failure
- Study on the Effects of Vericiguat in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF) Using the CardioMEMS HF System
- Germany
- Greece
- Hungary
- Study on Ferric Derisomaltose for Patients with Iron Deficiency and Chronic Heart Failure
- Study on Hydralazine, Isosorbide Dinitrate, and Metformin for Patients with Chronic Heart Failure and Reduced Heart Function
- Study on the Effects of AZD5462 for Patients with Stable Chronic Heart Failure
- Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack
- Study on the Safety of Starting Vericiguat at 5 mg in Patients with Chronic Heart Failure with Reduced Ejection Fraction
- Italy
- Latvia
Study on Ferric Derisomaltose for Patients with Iron Deficiency and Chronic Heart Failure
This trial is investigating ferric derisomaltose, an intravenous iron treatment, for patients who have both chronic heart failure and iron deficiency. The study aims to determine whether correcting iron deficiency can help reduce deaths related to heart problems and decrease the number of hospital admissions due to worsening heart failure.
Main inclusion criteria: Participants must be adults aged 18 or older with a left ventricular ejection fraction of 45% or less, indicating reduced heart pumping ability. They should have documented heart failure classified as NYHA class II, III, or IV, and be receiving the maximum tolerated medical therapy. Iron deficiency must be confirmed through blood tests showing either low ferritin levels (less than 100 ng/mL) or low transferrin saturation (less than 20%). Additionally, participants must show evidence of higher-risk heart failure, such as recent hospitalization or elevated natriuretic peptide levels.
Main exclusion criteria: Patients without confirmed chronic heart failure or iron deficiency cannot participate. Those not experiencing symptoms or not within the specified age range are also excluded, as are individuals from vulnerable populations who may require special protection.
Trial focus: The study compares intravenous ferric derisomaltose treatment to no iron treatment over an extended monitoring period. Researchers will track cardiovascular outcomes, hospital admissions, and changes in iron levels and heart failure symptoms throughout the trial.
Investigational treatment: Ferric derisomaltose is administered directly into the bloodstream through an intravenous infusion. This method allows iron to quickly replenish the body’s stores, potentially improving energy levels and reducing heart failure symptoms by supporting healthy red blood cell production and oxygen transport.
Study on the Effects of Vericiguat in Patients with Heart Failure with Reduced Ejection Fraction (HFrEF) Using the CardioMEMS HF System
This study examines vericiguat, a medication taken as a daily tablet, in patients with reduced heart pumping ability who have a CardioMEMS device implanted to monitor heart function. The trial aims to understand how vericiguat affects pulmonary artery pressure and heart failure markers.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of chronic heart failure and a left ventricular ejection fraction less than 45%. They should have NYHA functional class II-IV symptoms and be on stable, optimal heart failure medication. The CardioMEMS device must have been implanted at least two weeks before joining the study. Blood pressure must be at least 100 mmHg, and diastolic pulmonary artery pressure should be elevated based on CardioMEMS readings.
Main exclusion criteria: Individuals without the specific type of heart failure being studied or those outside the age requirements cannot participate. Vulnerable populations are also excluded.
Trial focus: This double-blind study randomly assigns participants to receive either vericiguat or placebo for 24 weeks. Regular monitoring includes measurements of pulmonary artery pressure through the CardioMEMS system, assessments of heart function through echocardiography, and blood tests for heart failure biomarkers.
Investigational treatment: Vericiguat works by stimulating an enzyme called soluble guanylate cyclase, which helps blood vessels relax and improves blood flow, thereby reducing the heart’s workload. The medication is available in 2.5 mg, 5 mg, or 10 mg tablets, with dosage adjusted based on individual response.
Study on Vitamin D and Oral Iron for Patients with Chronic Heart Failure and Iron Deficiency
This 24-week trial compares two approaches to treating iron deficiency in heart failure patients: a combination of vitamin D with oral iron (sucrosomial iron) versus intravenous iron (ferric carboxymaltose). The goal is to determine whether the oral combination can be as effective as the intravenous treatment.
Main inclusion criteria: Participants must have stable chronic heart failure with NYHA functional class II-III symptoms and no recent hospitalizations or emergency visits in the past three weeks. They should be on optimal heart failure medication without recent dose changes (except diuretics). A left ventricular ejection fraction of 45% or less and elevated brain natriuretic peptide levels are required. Iron deficiency must be confirmed through blood tests, and vitamin D levels must be below 50 nmol/L. Participants must be able to complete a 6-minute walking test.
Main exclusion criteria: Patients without both chronic heart failure and iron deficiency cannot participate. Those outside the specified age range or from vulnerable populations are also excluded.
Trial focus: The primary measure of success is improvement in the distance participants can walk in six minutes, a common assessment of physical capacity in heart failure patients. The study also evaluates quality of life, heart function through echocardiograms, and various blood markers throughout the treatment period.
Investigational treatments: Sucrosomial iron is a newer form of oral iron designed for better absorption in the digestive system. It is combined with vitamin D, which may have additional benefits for heart muscle function. The comparison treatment is ferric carboxymaltose, an established intravenous iron supplement that delivers iron directly into the bloodstream.
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 whether injecting cardiac atrial stem cells directly into damaged heart tissue can improve heart function in patients with advanced heart failure following a heart attack. The cells are obtained from donor heart tissue and represent a regenerative medicine approach.
Main inclusion criteria: Participants must be adults over 18 years old with documented heart attack caused by narrowed coronary arteries. They must have areas of non-functioning heart muscle visible on imaging tests, with scar tissue confirmed by MRI. Heart pumping function (ejection fraction) must be between 25% and 45%. Candidates should require heart bypass surgery in the affected area. Women who can become pregnant must use effective birth control and have negative pregnancy tests.
Main exclusion criteria: The trial excludes individuals below 18 or above 65 years of age, those with active cancer or cancer history within five years, recent heart attack within 30 days, or participation in other trials. Severe kidney or liver disease, uncontrolled diabetes, active infections, pregnancy, breastfeeding, uncontrolled heart rhythm problems, and substance abuse are also exclusionary.
Trial focus: This safety-focused study monitors patients for heart-related complications after receiving the stem cell treatment during cardiac surgery. Researchers will assess heart function through echocardiography and MRI scans, measure the extent of heart damage, and evaluate exercise capacity through walking tests. The study tracks symptoms and overall health throughout the monitoring period.
Investigational treatment: The treatment involves cardiac atrial stem cells injected directly into specific areas of damaged heart muscle during surgery. These cells are derived from the atrial appendage of donor hearts and are being studied for their potential to promote cardiac tissue regeneration and improve heart function.
Study on Hydralazine, Isosorbide Dinitrate, and Metformin for Patients with Chronic Heart Failure and Reduced Heart Function
This long-term study, continuing until 2028, examines two different medication approaches for chronic heart failure: BiDil (a combination of hydralazine and isosorbide dinitrate) and metformin, a medication commonly used for diabetes. The trial aims to determine whether these treatments can reduce deaths and hospitalizations related to heart failure.
Main inclusion criteria: Participants must have chronic heart failure classified as NYHA class II, III, or IV with a left ventricular ejection fraction of 40% or less. They should be on optimal treatment including ACE inhibitors, ARBs, or ARNI, plus beta-blockers, unless medically contraindicated. If needed, cardiac devices like CRT or ICD should be appropriately implanted and used. For the hydralazine-isosorbide dinitrate portion, systolic blood pressure must be at least 100 mmHg with specific natriuretic peptide levels. For the metformin portion, participants must have diabetes or be at risk for diabetes with adequate kidney function.
Main exclusion criteria: Patients without chronic heart failure and reduced ejection fraction of 40% or less cannot participate. Those not on optimal treatment or outside the specified age range are excluded, as are vulnerable populations.
Trial focus: This double-blind study randomly assigns participants to receive active medications or placebo. Regular monitoring tracks death rates, cardiovascular hospitalizations including those for worsening heart failure, heart attacks, or strokes, and the need for urgent medical interventions.
Investigational treatments: BiDil combines hydralazine and isosorbide dinitrate, which work together to relax blood vessels, reducing the heart’s workload and improving blood flow. Metformin, while primarily used for diabetes, is being investigated for potential benefits in heart failure patients with diabetes or insulin resistance by improving insulin response and potentially affecting heart health.
Study on the Effects of Colchicine on Blood Vessel Function in Patients with Chronic Heart Failure and CHIP Mutations
This specialized trial investigates colchicine, an anti-inflammatory medication, in patients with chronic heart failure who also have specific genetic changes in their blood cells called CHIP mutations (specifically DNMT3A and TET2). The study focuses on how colchicine affects blood vessel function and inflammation.
Main inclusion criteria: Participants must be at least 18 years old with ischemic cardiomyopathy and reduced left ventricular function (LVEF 40% or less). They should have stable heart insufficiency classified as NYHA II-III and be on constant optimal medical treatment for at least four weeks. A known status of CHIP mutations must be confirmed. Women of childbearing potential need negative pregnancy tests and must use highly effective contraception.
Main exclusion criteria: Individuals without chronic heart failure, those outside the age requirements, or from vulnerable populations cannot participate.
Trial focus: This randomized, controlled study monitors endothelial function (how well blood vessel linings work) using flow-mediated dilation measurements. The trial compares these measurements in patients with and without CHIP mutations before and after treatment with colchicine or placebo. Researchers also monitor inflammatory biomarkers and genetic signatures related to inflammation.
Investigational treatment: Colchicine is taken orally as 0.5 mg tablets. It works by disrupting microtubule formation in cells, which reduces inflammation by preventing certain immune cells from becoming activated and moving to sites of inflammation. The trial specifically examines whether this anti-inflammatory effect can improve blood vessel function in this unique patient population.
Study on the Effects of Trimetazidine on Heart Failure with Preserved Ejection Fraction in Patients
This study examines trimetazidine in a specific type of heart failure where the heart’s pumping ability appears normal but the heart chambers cannot fill properly with blood. The trial, running until late 2027, investigates whether this medication can improve outcomes in patients with heart failure with preserved ejection fraction.
Main inclusion criteria: Participants must be between 55 and 85 years old with NYHA Class I to III symptoms and documented heart failure with preserved ejection fraction, confirmed by a heart specialist using specific diagnostic criteria. Left ventricular ejection fraction must be 50% or higher on echocardiogram. Heart failure medication must remain unchanged for at least three months before screening. High-sensitivity C-reactive protein levels must be 1.5 mg/L or higher, indicating inflammation.
Main exclusion criteria: Recent heart attacks within three months, uncontrolled high blood pressure, severe kidney or liver disease, current participation in other trials, pregnancy or breastfeeding, history of severe allergic reactions to study medications, and uncontrolled heart rhythm problems are among the exclusionary criteria.
Trial focus: The study tracks time to hospitalization or serious health events related to heart conditions. Regular assessments measure heart function, quality of life, inflammation markers, and other health indicators to understand the medication’s impact on this specific heart failure type.
Investigational treatment: Trimetazidine (Trimeductan MR) is a 35 mg modified-release tablet taken orally. It works by optimizing energy production in heart cells, helping them function more efficiently under stress. This metabolic agent aims to improve heart muscle performance without directly affecting heart rate or blood pressure.
Study on the Effects of AZD5462 for Patients with Stable Chronic Heart Failure
This trial studies AZD5462, an experimental medication, in patients with stable chronic heart failure over a 24-week treatment period. The goal is to understand the medication’s effects and determine the optimal dosage for treating this condition.
Main inclusion criteria: Participants must be between 18 and 85 years old with a confirmed chronic heart failure diagnosis classified as NYHA functional class II to IV. They should be on stable heart failure medications for at least four weeks, with a minimum body mass index of 18 kg/m². Left ventricular ejection fraction and NT-pro-BNP levels must meet study criteria confirmed during screening. Female participants must not be able to have children, and all participants must provide informed consent.
Main exclusion criteria: Individuals without chronic heart failure, those outside the age range, vulnerable populations, or those unable to follow study procedures cannot participate. Any other medical conditions that might interfere with the study or make participation unsafe are also exclusionary.
Trial focus: This double-blind study randomly assigns participants to receive either AZD5462 or placebo. Regular follow-up assessments measure changes in heart function through echocardiography, evaluate health status using standardized questionnaires, and monitor cardiac biomarkers to track the medication’s effects on heart failure symptoms and progression.
Investigational treatment: AZD5462 is taken orally as a film-coated tablet. It is classified as a cardiovascular agent and works by modulating specific pathways involved in heart muscle contraction and relaxation, though the exact mechanism remains under investigation during this experimental phase.
Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack
This trial investigates CDR132L in patients who have experienced a heart attack and now have reduced heart pumping ability. The study evaluates whether this novel treatment can improve heart function and reduce symptoms associated with heart failure developing after a heart attack.
Main inclusion criteria: Participants must be adults between 30 and 80 years old who experienced a spontaneous acute myocardial infarction within 14 days before joining the study. Left ventricular ejection fraction must be 45% or less as measured after the heart attack. Body weight must not exceed 120 kg. NT-proBNP levels must fall between 125 pg/ml and 8000 pg/ml at screening. Participants must have undergone percutaneous coronary intervention for the heart attack, and those with previous heart attacks may participate.
Main exclusion criteria: Patients with recent heart attacks or acute left-sided heart failure who are not receiving standard care treatment cannot participate. Vulnerable populations are also excluded.
Trial focus: Participants are randomly assigned to one of three groups receiving either low-dose CDR132L, high-dose CDR132L, or placebo. Treatment consists of three intravenous infusions given 28 days apart. Regular monitoring includes heart imaging tests, blood tests, physical examinations, and assessments of overall health to track improvements in heart function and identify any side effects.
Investigational treatment: CDR132L is administered through intravenous infusion in doses of either 5 mg/kg or 10 mg/kg. This investigational medication targets specific molecules involved in heart muscle repair and function, though its exact mechanism is still being studied in this Phase 2 clinical trial.
Study on the Effects of Digoxin and Activated Charcoal in Treating Heart Failure in Patients Receiving Standard Care
This study evaluates how well the traditional heart medication digoxin works when combined with modern heart failure treatments. The trial examines digoxin’s effects on heart function and patients’ ability to perform physical activities over a 24-week period.
Main inclusion criteria: Participants must be at least 18 years old with chronic heart failure and reduced ejection fraction (LVEF 45% or less). They should have symptomatic heart failure with at least NYHA class II classification. Participants must have been on the maximum tolerated doses of standard heart medications including ARNi or ACEi, beta-blockers, SGLT2 inhibitors, and MRA for at least six months unless contraindicated. All participants must be able to provide informed consent and willing to follow study procedures.
Main exclusion criteria: Patients without heart failure diagnosis, those outside the age range, or from vulnerable populations cannot participate.
Trial focus: The study monitors peak oxygen consumption and cardiac function at 24 weeks as primary measures. Secondary outcomes include tracking hospitalizations, changes in blood markers related to heart health, and overall quality of life. Researchers aim to understand whether digoxin provides additional benefits when added to contemporary heart failure treatment regimens.
Investigational treatment: Digoxin (Lanoxin MD) is administered as 0.125 mg tablets taken orally. This cardiac glycoside works by inhibiting the sodium-potassium ATPase enzyme, which increases calcium in heart cells and leads to stronger heart contractions. While digoxin has been used for many years, this trial specifically evaluates its role alongside newer heart failure medications.
Study on the Safety of Starting Vericiguat at 5 mg in Patients with Chronic Heart Failure with Reduced Ejection Fraction
This short-term, two-week study focuses on evaluating the safety and tolerability of starting vericiguat treatment at a 5 mg dose in patients with chronic heart failure and reduced ejection fraction. The trial examines whether patients can safely complete the initial treatment period without significant side effects.
Main inclusion criteria: Participants must have chronic heart failure with reduced ejection fraction (less than 45%) and systolic blood pressure of at least 100 mmHg at study start. Heart failure medications must remain at stable doses for a specified period, and no medical procedures should be planned two weeks before or during the study. Participants may or may not have experienced recent worsening heart failure events. Both male and female adult participants are eligible.
Main exclusion criteria: Individuals without chronic heart failure with reduced ejection fraction, those outside the specified age range, or from vulnerable populations cannot participate.
Trial focus: The primary goal is determining whether participants can complete the two-week course of vericiguat 5 mg without stopping medication due to side effects or experiencing moderate to severe low blood pressure. Researchers monitor tolerability, blood pressure changes, and any adverse effects that occur during this initial treatment period. Successful completion is defined by continuous medication intake without significant issues.
Investigational treatment: Vericiguat is taken as a 5 mg film-coated tablet once daily for two weeks. As a soluble guanylate cyclase stimulator, it helps relax blood vessels and improve blood flow. This Phase 2b open-label study specifically assesses whether this starting dose is safe and well-tolerated before longer-term treatment.
Summary
These 11 clinical trials represent diverse approaches to treating chronic heart failure, ranging from addressing iron deficiency to testing innovative cell-based therapies and evaluating both traditional and novel medications. A notable concentration of trials is occurring in Central and Eastern European countries, with Hungary, Poland, and Czechia participating in multiple studies. Several trials focus specifically on iron supplementation, reflecting growing recognition of iron deficiency’s role in heart failure progression. The studies employ various treatment approaches including intravenous and oral medications, with some examining combination therapies and others testing entirely new therapeutic strategies like stem cell injections.
The trials encompass different types of heart failure, including those with reduced ejection fraction and preserved ejection fraction, and include both stable patients and those who have recently experienced heart attacks. Treatment durations range from short two-week safety studies to long-term trials extending into 2028. Many studies include specific patient populations, such as those with genetic mutations or diabetes, reflecting a move toward more personalized medicine approaches.
Participants interested in these trials should discuss eligibility with their healthcare providers, as each study has specific requirements regarding heart function measurements, medication history, and overall health status. The diversity of these trials offers potential opportunities for patients with various presentations of chronic heart failure to access innovative treatments while contributing to advancing medical knowledge in this field.
