Cardiac failure – Trials in Disease

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Ongoing Clinical Trials for Cardiac Failure

This article provides information about 37 ongoing clinical trials investigating treatments for cardiac failure (also known as: heart failure, congestive heart failure). These studies are testing various medications and therapies across multiple countries in Europe, with trials taking place in Denmark, France, Poland, Spain, Germany, and many other locations. The trials explore different approaches including new medications, combinations of existing drugs, and innovative therapies aimed at improving heart function and quality of life for patients with various types of heart failure.

Clinical trial locations

Overview of Clinical Trials

The following section describes the first 10 clinical trials for cardiac failure in detail. Additional trials are available and can be found through the provided links.

Comparing Carvedilol and Metoprolol Succinate for Treating Heart Failure with Reduced Ejection Fraction in Patients at Heart Failure Clinics

This study, known as CROWD-COMPARE, is being conducted in Denmark and focuses on patients with heart failure with reduced ejection fraction. The trial aims to compare two beta-blocker medications: Carvedilol and Metoprolol succinate. Both medications help slow the heart rate and reduce blood pressure, making it easier for the heart to pump blood effectively.

Main inclusion criteria: Patients must have heart failure with reduced ejection fraction, be registered in the Danish Heart Failure Registry, and have filled at least one prescription for either Carvedilol or Metoprolol succinate. Both men and women can participate.

Main exclusion criteria: Patients without heart failure or without an indication for beta-blocker treatment cannot participate. Those not within the specified age range or who are part of a vulnerable population are also excluded.

Focus of the trial: The study will follow patients over time to determine which medication is more effective in reducing the risk of death from any cause or the first hospitalization due to worsening heart failure. The trial is expected to continue until 2029.

Investigational drugs: Carvedilol is provided as a 25 mg film-coated tablet, while Metoprolol succinate is provided as a 190 mg prolonged-release tablet. Both are taken orally.

Comparing Spironolactone and Eplerenone for Patients with Heart Failure and Reduced Ejection Fraction

This trial, called CROWD-ASPECT, is taking place in Denmark and examines two aldosterone antagonist medications: spironolactone and eplerenone. These medications help the body eliminate excess salt and water, reducing the workload on the heart.

Main inclusion criteria: Patients must be registered in the Danish Heart Failure Registry, have reduced ejection fraction, and have filled at least one prescription for an aldosterone antagonist. Both men and women can participate.

Main exclusion criteria: Patients with a history of heart failure who are not eligible for aldosterone antagonist treatment, or those not within the specified age range cannot participate. Vulnerable populations are also excluded.

Focus of the trial: The study tracks the occurrence of death or hospitalization due to heart failure as key outcomes. Participants will receive either spironolactone, eplerenone, or a placebo, and will be monitored until the end of 2028.

Investigational drugs: Spironolactone and eplerenone are both taken orally in the form of film-coated tablets. The specific dosage is determined by the study team.

Evaluating the Effect of Vicadrostat and Empagliflozin Combination Compared to Empagliflozin Alone in Patients with Heart Failure and Reduced Left Ventricular Function

This international trial is being conducted across multiple countries including Poland, Slovakia, Czechia, Hungary, Germany, Bulgaria, Netherlands, Romania, Spain, Belgium, Denmark, and Italy. It tests whether combining vicadrostat with empagliflozin is more effective than empagliflozin alone for treating heart failure with reduced ejection fraction.

Main inclusion criteria: Patients must have chronic heart failure diagnosed at least 3 months before joining, with a left ventricular ejection fraction less than 40%. They must be at least 18 years old and have elevated NT-proBNP levels.

Main exclusion criteria: Patients with severe kidney disease, elevated potassium levels, very low blood pressure, pregnancy, breastfeeding, or planned cardiac surgery are excluded.

Focus of the trial: The study monitors cardiovascular death, heart failure hospitalizations, and urgent heart failure visits. It also assesses heart failure symptoms using questionnaires. The treatment period lasts 36 weeks.

Investigational drugs: Vicadrostat (BI 690517) and empagliflozin are provided as film-coated tablets taken orally. All participants receive empagliflozin, while some also receive vicadrostat.

Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

This study is taking place in Poland and focuses on people with high cardiovascular risk, including those who have experienced long-COVID syndrome. The research examines whether allopurinol, a medication that lowers uric acid levels, can help reduce the risk of cardiovascular events.

Main inclusion criteria: Participants must be between 40 and 70 years old with blood uric acid levels above 5mg/dl. They must meet at least one high cardiovascular risk condition, such as having had a stroke, heart failure, poor blood flow to legs, irregular heartbeat, diabetes, or high blood pressure with organ damage.

Main exclusion criteria: Current treatment with allopurinol, known allergy to allopurinol, severe kidney or liver disease, active cancer, pregnancy, breastfeeding, participation in other trials, and several other serious medical conditions are exclusion criteria.

Focus of the trial: The treatment will continue for approximately 5 years, during which participants will have regular check-ups including heart examinations, blood vessel examinations, blood tests, blood pressure measurements, and heart rhythm checks.

Investigational drugs: Allopurinol tablets are taken orally. The medication blocks an enzyme that produces uric acid in the body, potentially helping to protect the heart and blood vessels.

Study of maridebart cafraglutide for patients with heart failure with preserved or mildly reduced ejection fraction and obesity

This large international trial is being conducted in Poland, Greece, Italy, Germany, Czechia, Slovakia, Romania, Hungary, Bulgaria, Sweden, France, Spain, Portugal, Belgium, Pologne, Austria, Netherlands, Denmark, and Finland. It investigates maridebart cafraglutide (AMG 133) for patients with heart failure who also have obesity.

Main inclusion criteria: Patients must be at least 18 years old with a BMI of 30 or higher. They must have heart failure with preserved or mildly reduced ejection fraction, elevated NT-proBNP levels, and specific heart structure changes or recent hospitalizations for heart failure.

Main exclusion criteria: Age below 18, BMI less than 30, severe heart failure symptoms, pregnancy, breastfeeding, severe allergic reactions to similar medications, and participation in other trials within the last 30 days are exclusion criteria.

Focus of the trial: The study monitors heart-related events such as hospitalization for heart failure, urgent heart failure visits, or heart-related health issues. Participants complete questionnaires about symptoms and quality of life at week 48. The study runs until September 2030.

Investigational drugs: Maridebart cafraglutide is given as an injection under the skin. It is designed to target and reduce levels of a molecule called miR-132, potentially improving heart structure and function.

Study on Balcinrenone and Dapagliflozin for Patients with Heart Failure and Kidney Problems

This trial is being conducted in Romania, France, Poland, Czechia, Germany, Slovakia, Austria, Hungary, Bulgaria, Finland, Sweden, Netherlands, Italy, Greece, and Spain. It tests the combination of balcinrenone and dapagliflozin compared to dapagliflozin alone for patients with heart failure and impaired kidney function.

Main inclusion criteria: Patients must be 18 years or older with symptomatic heart failure, a recent heart failure event within the last 6 months, and an eGFR between 20 and less than 60 mL/min/1.73 m². They must not be taking an MRA and must have serum potassium levels between 3.5 and 5.0 mmol/L.

Main exclusion criteria: Patients without a recent heart failure event, without chronic heart failure, without impaired kidney function, or not at risk of cardiovascular death or heart failure events cannot participate.

Focus of the trial: The study monitors heart failure events and cardiovascular death over a period lasting until June 2027. Regular follow-up visits assess health status and any side effects.

Investigational drugs: Balcinrenone is provided in hard capsules, while dapagliflozin is provided in film-coated tablets, both taken orally.

Study on BI 690517 and Empagliflozin for Patients with Heart Failure and Preserved Ejection Fraction

This trial is taking place in Czechia, Bulgaria, Hungary, Poland, Slovenia, Germany, Romania, Spain, Belgium, Netherlands, and Italy. It examines whether combining BI 690517 with empagliflozin is more effective than empagliflozin with placebo for treating heart failure with preserved ejection fraction.

Main inclusion criteria: Patients must be at least 18 years old with chronic heart failure for at least 3 months, NYHA class II-IV symptoms, and a left ventricular ejection fraction of 40% or higher. They must have structural heart abnormalities and elevated NT-proBNP levels.

Main exclusion criteria: Patients with severe allergic reactions to study medications, uncontrolled high blood pressure, severe kidney or liver disease, pregnancy, breastfeeding, drug or alcohol abuse in the past year, and other serious medical conditions are excluded.

Focus of the trial: The treatment period lasts 42 days, during which participants are monitored for heart failure events and changes in symptoms. The trial is expected to conclude by November 5, 2027.

Investigational drugs: BI 690517 and empagliflozin are administered orally in film-coated tablets. BI 690517 works by blocking aldosterone receptors, while empagliflozin inhibits SGLT2 in the kidneys.

Study on Colchicine and Thiamine for Patients with Heart Failure from Ischemic Heart Disease

This trial is being conducted in Italy and focuses on patients with heart failure caused by ischemic heart disease. It tests whether colchicine or thiamine can reduce the risk of serious heart-related events.

Main inclusion criteria: Patients must be 45 years old or older with ischemic heart disease as the cause of heart failure. They must have NYHA class II-IV symptoms, a left ventricular ejection fraction of 45% or less, and be receiving the best possible medical treatment.

Main exclusion criteria: Patients without heart failure, without ischemic heart disease, or not within the specified age range cannot participate. Gender is not an exclusion criterion, and vulnerable populations are not excluded.

Focus of the trial: The study is expected to conclude by April 2028. Participants are monitored for heart failure events and overall heart health throughout the study period.

Investigational drugs: Colchicine is administered as a 0.5 mg tablet, while thiamine is administered as a 300 mg gastro-resistant tablet, both taken orally.

Study on Dapagliflozin for Patients with Chronic Right Heart Failure

This study is taking place in Germany and examines the effects of dapagliflozin in patients with chronic right heart failure. The trial aims to determine if dapagliflozin, when added to usual care, is more effective than usual care plus a placebo.

Main inclusion criteria: Patients must be between 18 and 89 years old with chronic right heart failure, defined by specific heart function measurements. They must have elevated NT-proBNP levels and signs of right heart congestion. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.

Main exclusion criteria: Patients without chronic right heart failure, not within the specified age range, or part of a vulnerable population cannot participate.

Focus of the trial: The treatment period lasts approximately three months. Throughout the study, changes in NT-proBNP levels, quality of life, heart function, and exercise capacity are monitored.

Investigational drugs: Dapagliflozin is taken orally in tablet form. It works by inhibiting SGLT2 in the kidneys, which helps reduce blood sugar levels and may have beneficial effects on heart health.

Study on Heart Failure Patients Using Hyperpolarized [1-13C]pyruvate to Explore Heart Metabolism

This trial is being conducted in Denmark and uses a special form of pyruvic acid called Hyperpolarized [1-13C]pyruvate to study heart metabolism in patients with heart failure. The substance is given as an injection and helps visualize the heart’s metabolism using magnetic resonance imaging.

Main inclusion criteria: Patients must have chronic heart failure (both reduced and preserved ejection fraction), be over 18 years old, and have a left ventricular ejection fraction between 10% and 60%. They must have adequate blood and organ function and be Danish speaking.

Main exclusion criteria: Patients with heart failure cannot participate in the study, which appears to be a documentation error as the inclusion criteria specifically require heart failure.

Focus of the trial: The study observes how the heart metabolizes the injected substance and compares these findings with existing diagnostic methods. This research could provide new insights into heart function.

Investigational drugs: Hyperpolarized [1-13C]-pyruvate is administered through intravenous injection. It is used to enhance imaging techniques by tracking metabolic processes in the heart.

Summary

The 37 ongoing clinical trials for cardiac failure span multiple European countries, with notable concentrations in Denmark, Germany, Poland, Spain, and the Netherlands. Many trials are multinational, reflecting the global nature of cardiovascular research.

Several trials focus on medication combinations, particularly investigating whether adding newer agents to established treatments can improve outcomes. SGLT2 inhibitors, such as empagliflozin and dapagliflozin, appear frequently across multiple studies, either as monotherapy or in combination with other agents. This reflects the growing recognition of SGLT2 inhibitors’ benefits in heart failure management.

A significant number of trials specifically target heart failure with preserved ejection fraction (HFpEF), an area where treatment options have historically been limited. Studies are investigating novel approaches including maridebart cafraglutide for patients with obesity, and various mineralocorticoid receptor antagonists for different patient populations.

Several trials focus on special populations, including elderly patients with kidney disease, patients who cannot tolerate standard medications, and even pediatric patients. One notable study examines cardiac atrial stem cells as a regenerative therapy approach.

The trials employ diverse methodologies, from traditional medication comparisons to innovative imaging techniques using hyperpolarized substances to study heart metabolism. Treatment durations range from weeks to several years, with some extension studies following patients long-term to assess safety and efficacy.

Many trials monitor not only cardiovascular events and mortality but also quality of life measures, exercise capacity, and symptom scores, reflecting a holistic approach to evaluating treatment effectiveness. The research represents a comprehensive effort to advance treatment options for various types and stages of heart failure.

Ongoing Clinical Trials on Cardiac failure

  • Study of PF-07328948 tablets compared to placebo in adults with heart failure to evaluate effects on symptoms and physical function

    Recruiting

    2 1
    Investigated diseases:
    Bulgaria Czechia France Hungary Poland Spain
  • Study of Zenagamtide (NNC0487-0111) versus placebo in patients with heart failure with preserved or mildly reduced ejection fraction and obesity

    Recruiting

    3 1
    Investigated diseases:
    Bulgaria Czechia Denmark France Germany Greece +4
  • A study testing the reduction of heart failure drug combination in patients with heart failure in remission

    Recruiting

    3 1 1 1
    Investigated diseases:
    Belgium
  • Study on the Effects of CDR132L on Heart Structure and Function in Patients with Heart Failure and Left Ventricular Hypertrophy

    Recruiting

    2 1
    Investigated diseases:
    Germany Poland Spain
  • Study on CDR132L for Heart Failure with Reduced Ejection Fraction and Left Ventricular Hypertrophy in Adults

    Recruiting

    2 1
    Investigated diseases:
    Czechia Germany The Netherlands Poland Spain
  • Study on the Effects of Intraperitoneal Furosemide in Patients with Heart Failure on Peritoneal Dialysis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Spain
  • Study on the Effects of Ferric Derisomaltose on Cognitive Function in Heart Failure Patients with Iron Deficiency

    Recruiting

    3 1 1
    Investigated diseases:
    Germany
  • Study on BI 690517 and Empagliflozin for Patients with Heart Failure and Preserved Ejection Fraction

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Germany Hungary Italy +5
  • Study on Balcinrenone and Dapagliflozin for Patients with Heart Failure and Kidney Problems

    Recruiting

    3 1 1
    Investigated diseases:
    Austria Bulgaria Czechia Finland France Germany +9
  • Study on the Effects of Perindopril, Valsartan, and Glyceryl Trinitrate in Women with Asymptomatic Heart Failure

    Recruiting

    3 1 1 1
    Investigated diseases:
    The Netherlands