Ongoing Clinical Trials for Acute Heart Failure
Thirteen clinical trials are currently underway across Europe to test new treatments for acute heart failure, a serious condition where the heart suddenly cannot pump blood effectively. These studies are evaluating various medications, including diuretics, SGLT2 inhibitors, beta-blockers, and novel therapies, to improve outcomes for patients experiencing sudden worsening of heart function.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- Germany
- Study on the Safety and Effectiveness of Engineered Human Myocardium for Patients with Terminal Heart Failure
- Study of empagliflozin compared to placebo in patients with acute decompensated heart failure who are already taking SGLT2 inhibitors
- Study on AP-01 for Patients with Acute Heart Failure (NYHA Class III or Higher)
- Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Spain
- Study on Beta-Blockers for Patients with Takotsubo Syndrome: Evaluating Selective, Non-Selective, and Alpha-Beta Blocking Agents
- Study on Using Furosemide and Hydrochlorothiazide for Treating Patients with Acute Heart Failure
- Study on Colchicine for Patients with Acute Heart Failure
- Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack
Comparison of Furosemide, Nitrates, or Their Combination for Initial Treatment of Pulmonary Congestion in Patients with Acute Heart Failure
This trial is testing the best emergency treatment for patients admitted to hospital with fluid buildup in the lungs due to sudden heart failure. Researchers are comparing three approaches: using furosemide alone, using nitrates alone, or combining both medications.
Inclusion criteria: Adults 18 years or older experiencing sudden or worsening difficulty breathing, with systolic blood pressure of at least 100 mmHg, oxygen saturation below 94% or requiring oxygen support, and showing signs of fluid retention such as leg swelling or crackling sounds in the lungs.
Exclusion criteria: Patients requiring dialysis for severe kidney problems, those who had a heart attack in the last 30 days, those with severe liver disease, pregnant or breastfeeding women, patients with allergies to the study medications, current participation in another trial, uncontrolled high blood pressure, severe lung disease, or unstable mental health conditions.
Main focus: The study aims to determine which treatment strategy most effectively removes fluid from the lungs within three hours of hospital admission. Researchers will measure the number of days patients remain alive and out of hospital until day 30, as well as assess breathing improvement and overall clinical benefit.
Investigational drugs: Furosemide helps remove excess fluid by increasing urine production. Nitrates relax blood vessels to reduce the heart’s workload. The combination approach provides benefits of both medications.
Study of Metolazone and Acetazolamide Combination for Patients with Acute Heart Failure and Volume Overload
This trial focuses on patients with heart failure who have excess fluid and may not respond well to standard water pill treatments. The study compares metolazone tablets and acetazolamide injections with inactive treatments over a 4-day hospital stay.
Inclusion criteria: Adults 18 years or older admitted with heart failure, taking at least 40 mg daily of furosemide for at least 7 days before admission or not responding to high-dose water pills in the last 24 hours, with signs of fluid overload such as leg swelling, fluid in abdomen, swollen neck veins, or fluid in lungs.
Exclusion criteria: Age below 18 or above 85 years, allergies to diuretic medications, severe kidney failure requiring dialysis, cardiogenic shock, pregnancy or breastfeeding, participation in another trial within 30 days, life expectancy less than 6 months, severe liver disease, uncontrolled high blood pressure, systemic infection, recent heart attack or stroke, inability to provide consent, history of serious allergic reactions, or severe mental illness.
Main focus: The trial evaluates whether adding these alternative diuretics can improve fluid removal in patients who don’t respond adequately to standard treatments. Researchers will monitor 24-hour fluid loss, weight changes, and kidney function during the hospital stay and for 90 days afterward.
Investigational drugs: Metolazone is taken by mouth and helps kidneys remove more water and salt. Acetazolamide is given through injection and works through a different mechanism to reduce fluid buildup. Both are types of water pills that complement standard treatments.
Study on Beta-Blockers for Patients with Takotsubo Syndrome: Evaluating Selective, Non-Selective, and Alpha-Beta Blocking Agents
This study examines Takotsubo Syndrome, an acute heart condition often triggered by severe stress. The trial tests three types of beta-blocker medications: selective beta-blockers like nebivolol and metoprolol, non-selective beta-blockers such as propranolol, and beta-blockers with alpha activity like carvedilol.
Inclusion criteria: Adults over 18 years with written informed consent and a diagnosis of Takotsubo Syndrome confirmed by tests, excluding significant coronary artery disease.
Exclusion criteria: Patients with a different heart condition not related to Takotsubo Syndrome, current participation in another trial, history of severe allergic reactions to study medications, pregnancy or breastfeeding, serious illness like advanced cancer, inability to follow study procedures, history of substance abuse, or mental health conditions interfering with consent.
Main focus: The study evaluates how well beta-blockers help the heart recover over 24 weeks. Researchers will use echocardiography to measure improvements in heart function, specifically the left ventricular wall motion score at 7 days, and monitor for adverse clinical events.
Investigational drugs: Beta-blockers slow down heart rate and reduce the heart’s workload. The trial specifically tests beta-blockers with additional properties such as alpha activity or nitric oxide release to determine if they offer extra benefits in improving heart function in Takotsubo Syndrome.
Study on Empagliflozin and Dapagliflozin for Patients Hospitalized with Acute Heart Failure
This trial investigates the effects of SGLT-2 inhibitors in patients hospitalized due to sudden worsening of heart failure. Participants receive either empagliflozin, dapagliflozin, or placebo while being closely monitored over several months.
Inclusion criteria: Adults at least 18 years old with kidney function (eGFR) greater than 20 ml/min/1.73m², currently hospitalized with acute heart failure including fluid buildup, randomized between 24 hours and 10 days after admission while stable, systolic blood pressure above 100 mmHg for at least 6 hours, no increase in IV diuretics or use of IV vasodilators in last 6 hours, no IV inotropes in last 24 hours, and elevated NT-proBNP levels during hospital stay.
Exclusion criteria: Patients with acute or decompensated heart failure currently worsening.
Main focus: The study monitors whether these medications reduce complications such as worsening heart failure or need for additional hospital visits. Researchers assess kidney function, overall quality of life, and conduct regular tests to evaluate heart function and overall health throughout the trial.
Investigational drugs: Empagliflozin and dapagliflozin are SGLT-2 inhibitors taken as 10 mg tablets once daily. They help the body remove excess sugar through urine while having beneficial effects on heart function.
Study on the Safety and Effectiveness of Engineered Human Myocardium for Patients with Terminal Heart Failure
This innovative trial tests Engineered Human Myocardium, an implant made from special stem cells designed to support heart function. The treatment is surgically implanted into the heart to help it work better.
Inclusion criteria: Adults aged 18 to 80 years with heart failure with reduced ejection fraction confirmed by imaging tests, at least one non-moving heart section, stable condition allowing certain heart surgeries, having an implanted heart rhythm device, being in NYHA Class III or IV despite best medical treatment, willing to sign consent, and females of childbearing potential agreeing to reliable birth control.
Exclusion criteria: Patients without heart failure, heart function better than 35%, right ventricle function measurement of 16 mm or more, patients outside specified age range, or vulnerable populations.
Main focus: The study evaluates safety and effectiveness by monitoring for adverse events within 28 days after surgery and assessing improvements in heart structure and function through tests like echocardiography and MRI. Long-term monitoring includes tracking major cardiac events, immune rejection, and quality of life assessments.
Investigational drugs: Engineered Human Myocardium derived from stem cells is implanted through surgical intervention to assist heart function by acting as biological support tissue.
Study on Using Furosemide and Hydrochlorothiazide for Treating Patients with Acute Heart Failure
This trial compares a standard treatment approach with an intervention that uses measurements of abdominal pressure and ultrasound to guide treatment with diuretics. The goal is to resolve fluid buildup within the first 72 hours.
Inclusion criteria: Adults over 18 years with heart failure diagnosis based on latest guidelines, NT-proBNP greater than 1000 pg/mL or BNP greater than 250 pg/mL, bladder catheterization to measure abdominal pressure, presence of fluid buildup shown by swelling, fluid in abdomen, or around lungs, and signed informed consent.
Exclusion criteria: Patients not experiencing acute heart failure, outside specified age range, or part of vulnerable populations.
Main focus: The study evaluates which treatment approach is more effective in reducing fluid buildup by monitoring effectiveness through measurements and ultrasound guidance. Regular assessments determine the absence of fluid buildup after 72 hours using the ADVOR scale.
Investigational drugs: Furosemide is administered intravenously or orally to reduce fluid buildup. Hydrochlorothiazide is given as a tablet to maintain fluid reduction. Both are diuretics that help the body eliminate excess fluid.
Study of empagliflozin compared to placebo in patients with acute decompensated heart failure who are already taking SGLT2 inhibitors
This trial examines whether continuing SGLT2 inhibitor treatment during hospital admission for worsening heart failure is beneficial for patients who were already taking these medications before admission.
Inclusion criteria: Adults 18 years or older with acute decompensated heart failure, currently taking SGLT2 inhibitor medication, elevated BNP greater than 100 pg/ml or NT-proBNP greater than 300 pg/ml, able to provide written consent, and negative pregnancy test for women of childbearing potential.
Exclusion criteria: Age below 18 years, pregnancy or breastfeeding, known allergy to empagliflozin, severe kidney disease requiring dialysis, Type 1 diabetes, active liver disease, recent heart attack within 30 days, systolic blood pressure below 90 mmHg, recent stroke within 3 months, life-threatening conditions requiring intensive care, participation in another trial within 30 days, inability to provide consent, history of ketoacidosis, severe urinary tract or genital infection, or medications that may interact with study drug.
Main focus: The study monitors patients for 90 days after hospital admission, tracking survival rates, hospital readmissions, kidney function, body weight, and overall health status. Participants complete questionnaires about quality of life and symptoms at various points during the study.
Investigational drugs: Empagliflozin 10 mg tablets taken once daily help the kidneys remove excess sugar and fluid through urination, reducing heart workload and improving blood flow.
Study on Acetazolamide with Empagliflozin and Dapagliflozin for Patients with Acute Heart Failure and Fluid Retention
This study examines the combination of acetazolamide with SGLT2 inhibitors in patients experiencing volume overload. The trial evaluates whether this combination improves sodium and fluid removal from the body.
Inclusion criteria: Adults 18 years or older with heart failure, on regular treatment with loop diuretics of at least 40 mg furosemide or equivalent, and considered to have too much fluid by the cardiologist, requiring addition of SGLT2 inhibitor and IV loop diuretic therapy.
Exclusion criteria: Any other serious health condition interfering with the study, inability to follow study procedures, current participation in another trial, recent heart attack or stroke, severe kidney disease, pregnancy or breastfeeding, known allergy to study medication, history of drug or alcohol abuse, uncontrolled high blood pressure, or major surgery within the last month.
Main focus: The trial measures 24-hour sodium excretion as the primary endpoint, along with volume output, weight changes, and fluid buildup according to the ADVOR protocol. Additional evaluations include plasma volume changes and imaging assessments of heart, lungs, abdomen, and neck veins.
Investigational drugs: Acetazolamide increases urine production to remove excess fluid. SGLT2 inhibitors like Jardiance (empagliflozin) 10 mg and Forxiga (dapagliflozin) 10 mg help kidneys remove sugar and water through urine when combined with acetazolamide.
Study on AP-01 for Patients with Acute Heart Failure (NYHA Class III or Higher)
This trial tests AP-01, an investigational treatment given intravenously as an add-on therapy for patients with severe heart failure. The study compares it with placebo to evaluate its effects on heart metabolism.
Inclusion criteria: Adults over 18 years providing written informed consent, with unplanned hospital stay for acute heart failure including worsening difficulty breathing while sitting up, signs of heart failure on chest X-ray or CT scan, BNP greater than 500 pg/mL or NT-proBNP greater than 2000 pg/mL, serum lactate level of 18.0 mg/dl or higher, ejection fraction less than 40% by echocardiogram, ability to start medication within 12 hours after initial assessment, and systolic blood pressure between 90 and 165 mmHg.
Exclusion criteria: Patients not experiencing acute heart failure, outside specified age range, or part of vulnerable populations.
Main focus: The study measures reduction of lactate levels within 90 minutes after the first dose and NT-proBNP levels after 72 hours. Regular assessments including echocardiography and quality of life questionnaires track improvement, along with hospital stay duration, mortality, and re-hospitalization rates.
Investigational drugs: AP-01 is administered intravenously and aims to improve heart muscle cell metabolism by reducing lactate and NT-proBNP levels, markers of heart stress.
Study on Early Use of Ivabradine for Children with Heart Failure Due to Dilated Cardiomyopathy
This trial evaluates ivabradine in children with heart failure caused by dilated cardiomyopathy, a condition where the heart becomes enlarged and cannot pump blood effectively. The medication is given as film-coated tablets to help manage heart rate.
Inclusion criteria: Children older than 6 months and younger than 18 years with dilated cardiomyopathy defined by heart enlargement more than 2 standard deviations with reduced movement, ejection fraction less than 40%, episode of acute heart failure in last three months, systolic blood pressure above 50th percentile for age and height, and heart rate more than 20% above expected normal values for age.
Exclusion criteria: Any other serious heart condition besides the one being studied, recent heart attack, severe liver or kidney problems, pregnancy or breastfeeding, allergies to study medication, current participation in another trial, uncontrolled high blood pressure, history of drug or alcohol abuse, stroke in past six months, or certain irregular heartbeats.
Main focus: The study observes heart rate changes after 14 days of stable therapy, with a follow-up period of four months to assess longer-term effects. Researchers monitor NT-proBNP protein levels and left ventricle function to determine potential benefits of early ivabradine administration.
Investigational drugs: Ivabradine Accord 5 mg film-coated tablets taken orally work by slowing down heart rate, improving heart efficiency and reducing symptoms.
Summary
The thirteen ongoing trials demonstrate diverse approaches to treating acute heart failure across multiple European countries. Germany leads with four trials, followed by Spain with four trials (one appearing in multiple countries). The research spans various therapeutic strategies including diuretic combinations, SGLT2 inhibitors, beta-blockers, and innovative regenerative therapies.
Several trials focus on SGLT2 inhibitors like empagliflozin and dapagliflozin, reflecting current interest in this medication class for heart failure treatment. Multiple studies examine optimal diuretic strategies, including combinations of furosemide with other agents like nitrates, acetazolamide, and hydrochlorothiazide, addressing the common challenge of fluid overload in these patients.
Notable is the inclusion of specialized populations, such as the pediatric trial in Italy testing ivabradine for children with dilated cardiomyopathy, and innovative approaches like the German study testing engineered heart tissue implants. The multinational CDR132L trial spans seven countries, indicating significant research coordination across Europe for this investigational therapy targeting patients after heart attacks with reduced heart function.
These trials collectively aim to improve outcomes by addressing different aspects of acute heart failure management, from emergency treatment strategies to long-term stabilization, representing comprehensive efforts to advance care for this serious condition.
