Ongoing Clinical Trials for Aortic Stenosis
Currently, there are 11 clinical trials underway exploring different treatment approaches for patients with aortic stenosis, a condition where the heart’s aortic valve becomes narrowed and restricts blood flow. These studies are investigating medications, imaging techniques, and treatment strategies aimed at improving outcomes for patients undergoing valve replacement procedures or managing the condition before it reaches severe stages.
Clinical trial locations
- Belgium
- Denmark
- France
- Germany
- Study of beta blockers in patients with aortic stenosis undergoing transcatheter aortic valve replacement
- Study on Protamine Sulfate for Reducing Bleeding and Ischemic Events in Adults with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
- Study of Spironolactone and Dihydralazine for reducing heart muscle scarring in patients with severe aortic valve narrowing after valve replacement procedure
- Italy
- Netherlands
- Norway
- Portugal
- Spain
Study of beta blockers in patients with aortic stenosis undergoing transcatheter aortic valve replacement
This trial focuses on patients who are already taking beta-blocker medications and are scheduled for transcatheter aortic valve replacement, a minimally invasive procedure to replace a narrowed heart valve. The study examines how continuing beta-blocker treatment affects outcomes after the procedure.
Inclusion criteria: To participate, you must be at least 18 years old and have severe symptomatic aortic stenosis requiring elective TAVR. You need to have been taking beta-blocker medications for at least one month before joining the study. The study is open to both men and women who can understand and sign an informed consent form.
Exclusion criteria: You cannot participate if you have a known allergy to beta blockers, current or recent heart block, very low blood pressure (systolic below 90 mmHg), severe heart failure with fluid in the lungs, severe breathing problems or asthma, or if you’ve had a heart attack in the past three months. Other exclusions include severe kidney or liver disease, pregnancy or breastfeeding, inability to provide informed consent, current participation in another trial, or a history of not following medical treatment plans.
Focus and goals: The study aims to understand how beta-blocker treatment impacts outcomes for patients receiving valve replacement. Researchers will track various health outcomes for up to one year after the procedure, including monitoring for heart-related events such as heart failure, stroke, and heart rhythm problems. They will also assess how many patients need pacemakers or require hospital readmission during this period.
Investigational treatment: The medications being studied include selective beta-blockers, beta-blockers combined with thiazides, and alpha-beta blockers. These medications, which reduce heart rate and blood pressure, will be given by mouth for up to six months.
Study on Empagliflozin for Patients with Aortic Stenosis After Aortic Valve Replacement
This trial investigates whether Jardiance (empagliflozin) can help reduce the size of the heart’s left ventricle and improve symptoms in patients who have undergone aortic valve replacement. The study compares the effects of empagliflozin to a placebo over 12 months.
Inclusion criteria: Participants must have severe symptomatic aortic stenosis and have undergone surgical or transcatheter aortic valve replacement within the last 14 days. The study includes adults of both sexes who are not from vulnerable populations.
Exclusion criteria: You cannot participate if you have conditions other than aortic stenosis that might interfere with the study, have not undergone AVR, are not within the specified age range, are part of a vulnerable population, cannot follow study procedures, are currently participating in another trial, or have medical conditions that would make participation unsafe.
Focus and goals: The study monitors changes in the heart’s left ventricle over 12 months after valve replacement using imaging techniques like computed tomography and echocardiography. It also examines heart function and levels of NT-proBNP, a heart-related protein. The goal is to determine whether empagliflozin offers additional benefits to patients recovering from valve replacement surgery.
Investigational treatment: Empagliflozin belongs to a class of drugs called SGLT2 inhibitors. These medications help lower blood sugar levels by helping the kidneys remove sugar from the body through urine. In this trial, researchers are testing whether it can reduce the size of the heart’s left ventricle and improve symptoms.
Study on Protamine Sulfate and Sodium Chloride to Reduce Bleeding in Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
This study compares two approaches for administering protamine sulfate to see which method better reduces bleeding complications after TAVI. Protamine sulfate is used to counteract the effects of blood thinners and reduce bleeding.
Inclusion criteria: You must be over 18 years old and undergoing transfemoral TAVI with any commercially available transcatheter heart valve. You must provide written informed consent to participate.
Exclusion criteria: The study excludes patients with aortic stenosis who are not within the specified age range or who are part of a vulnerable population.
Focus and goals: The study monitors the risk of cardiovascular mortality or bleeding within 30 days after the TAVI procedure. Researchers will assess how protamine sulfate affects bleeding complications, changes in hemoglobin levels, hospital stay length, the need for blood transfusions, and major vascular complications. The goal is to determine which method of administering protamine sulfate is more effective in reducing these risks.
Investigational treatment: Protamine sulfate and sodium chloride are administered through intravenous injection or infusion during the study. Protamine works by reversing the effects of blood thinners like heparin, which are often used during surgeries to prevent blood clots.
Study on Protamine Sulfate for Reducing Bleeding and Ischemic Events in Adults with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
This trial evaluates the benefits of using protamine sulfate after TAVR, specifically looking at its impact on reducing major bleeding and major ischemic events, which are serious conditions where blood flow to the heart or brain is reduced.
Inclusion criteria: You must be 55 years or older, have severe aortic stenosis, and be scheduled for transfemoral TAVR. You must be willing to participate, able to understand the study, and have signed an informed consent form.
Exclusion criteria: You cannot participate if you are under 18 years old, do not have severe aortic stenosis, are not scheduled for transfemoral TAVR, or are part of a vulnerable population.
Focus and goals: Participants will receive either protamine sulfate or a placebo after their TAVR procedure. The study monitors participants for any bleeding or ischemic events for up to 60 hours after the procedure. Researchers also observe other outcomes such as in-hospital mortality, additional surgeries needed, and overall recovery of heart valve function.
Investigational treatment: Protamine sulfate is given as an intravenous bolus (a single, quick injection directly into a vein) to reverse the effects of heparin, a medication used during the procedure to prevent blood clots.
Study on Ticagrelor and Aspirin for Patients with Severe Aortic Stenosis After Heart Valve Replacement
This trial compares the effectiveness and safety of Ticagrelor and Aspirin in preventing health complications after TAVI. Both medications are antiplatelet treatments that help prevent blood clots, which can be a concern after heart procedures.
Inclusion criteria: You must provide informed consent, be over 18 years old, and have severe symptomatic aortic stenosis and be accepted for TAVI with any approved devices. You must also have at least one additional condition: diabetes mellitus, previous coronary artery disease, or previous peripheral arterial disease. You must have had a successful TAVI procedure and not be participating in other clinical trials.
Exclusion criteria: You cannot participate if you have a history of severe allergic reactions to study medications, have had a stroke or TIA in the past six months, had a recent heart attack, have active bleeding or high bleeding risk, severe liver disease, uncontrolled high blood pressure, are in another trial, are pregnant or breastfeeding, or have other medical conditions that would make participation unsafe.
Focus and goals: The study monitors participants for 12 months to observe significant health events such as heart attacks, strokes, or bleeding. Researchers aim to determine the most effective and safe treatment strategy for preventing complications after TAVI.
Investigational treatment: Ticagrelor helps prevent blood clots by stopping platelets from sticking together, which can reduce the risk of heart attacks or strokes. Aspirin also prevents blood clots by stopping platelets from clumping together, helping keep blood flowing smoothly.
Study on Aortic Stenosis: Evaluating Fludeoxyglucose (18F) for Patients with Conduction Disorders After Aortic Valve Procedures
This study uses positron emission tomography (PET) imaging with Fludeoxyglucose (18F) to observe how inflammation in the heart’s conduction pathways might affect heart function after percutaneous aortic valve replacement.
Inclusion criteria: You must be over 18 years old and have tight aortic stenosis defined by specific measurements from transthoracic echocardiography. You must have symptoms such as difficulty breathing at stage 2 or higher, or have a problematic stress test, or an ejection fraction below 50% if asymptomatic. Your blood vessel anatomy must allow for percutaneous femoral valve implantation, you must be affiliated with health insurance, and provide free, informed, written consent.
Exclusion criteria: You cannot participate if you have aortic stenosis (though this seems contradictory with inclusion criteria), are not within the specified age range, or are part of a vulnerable population.
Focus and goals: The study explores the relationship between inflammation and the development of conduction disorders, which are problems with the heart’s electrical system that can occur after valve replacement. Participants undergo PET scans to assess inflammation levels and are monitored for conduction disorders during hospitalization and for up to six months afterward. The study may also evaluate the need for a pacemaker.
Investigational treatment: Fludeoxyglucose (18F) is a substance injected into the body to help highlight areas of inflammation during PET scans. It mimics glucose, allowing it to show areas of increased metabolic activity, which often indicate inflammation or disease.
Study on Iron Infusion with Ferric Carboxymaltose for Elderly Patients with Severe Aortic Stenosis and Iron Deficiency Undergoing TAVI
This trial tests whether Ferinject (ferric carboxymaltose), an iron treatment given through intravenous infusion, can improve quality of life and exercise capacity in elderly patients with severe aortic stenosis and iron deficiency who are undergoing TAVI.
Inclusion criteria: You must be 65 years or older, have severe aortic stenosis and iron deficiency, and be undergoing a successful TAVI procedure. Iron deficiency is defined as ferritin levels below 100 micrograms per liter or transferrin saturation below 20%. You must be able to complete assessments for quality of life, exercise capacity, and cognitive function, and have signed an informed consent form.
Exclusion criteria: You cannot participate if you do not have severe aortic stenosis and iron deficiency, are not undergoing TAVI, are outside the specified age range, or belong to a vulnerable population.
Focus and goals: Over several months, participants will undergo various assessments including questionnaires and a 6-minute walk test to evaluate their progress. The main goal is to see if iron treatment can improve overall well-being and physical abilities in patients with severe aortic stenosis and iron deficiency.
Investigational treatment: Ferric carboxymaltose is an intravenous iron treatment given directly into the bloodstream to replenish iron stores in the body. Iron is essential for producing healthy red blood cells and carrying oxygen throughout the body.
Study on the Effects of Dapagliflozin for Patients with Aortic Stenosis Undergoing Valve Replacement
This trial investigates whether dapagliflozin, taken as a 10 mg film-coated tablet, can improve heart and kidney function after patients undergo TAVR. The study compares the effects of dapagliflozin to a placebo.
Inclusion criteria: You must have signed an informed consent form, be scheduled for TAVR to treat aortic stenosis, be between 18 and 85 years old, and have specific heart function measurements. Your kidney function (eGFR) should be more than 30 mL/min/1.73 m².
Exclusion criteria: You cannot participate if you have conditions other than aortic stenosis that might interfere with the study, have not undergone AVR, are not within the age range, are part of a vulnerable population, cannot follow study procedures, are in another trial, or have medical conditions making participation unsafe.
Focus and goals: The study monitors changes in heart and kidney health over time, tracking indicators such as heart muscle thickness and kidney function. The goal is to determine if dapagliflozin can help reduce heart muscle size, improve heart function, enhance kidney function, decrease the chances of heart failure worsening, and reduce the risk of death.
Investigational treatment: Dapagliflozin is an SGLT2 inhibitor that works by blocking a protein in the kidneys that reabsorbs glucose, thereby promoting glucose excretion in urine. It may have protective effects on the heart and kidneys.
Study on the Effects of Losartan Potassium in Patients with Mild to Moderate Aortic Stenosis
This study examines how Losartan Potassium, an angiotensin receptor blocker, impacts mild to moderate aortic stenosis. Participants will receive either Losartan Potassium or a placebo over 24 months.
Inclusion criteria: You must have mild to moderate aortic stenosis, be between 20 and 85 years old, have a left ventricular ejection fraction of at least 50%, have systolic blood pressure of at least 100 mmHg, and provide signed informed consent.
Exclusion criteria: You cannot participate if you have severe aortic stenosis, are not within the age range, are part of a vulnerable population, cannot follow study procedures or take the medication as required, or have other medical conditions that might interfere with the study or pose health risks.
Focus and goals: Over 24 months, participants undergo regular check-ups including echocardiography and MRI to see how the heart and valves are functioning and if there are any changes in heart structure or function. Doctors monitor the rate at which the valve narrows, changes in heart size and shape, how well the heart pumps blood, and blood markers indicating heart health. The goal is to determine if Losartan Potassium can slow the progression of aortic stenosis and improve heart function.
Investigational treatment: Losartan Potassium is an angiotensin receptor blocker that relaxes blood vessels, helping to lower blood pressure and improve blood flow.
Study of Spironolactone and Dihydralazine for reducing heart muscle scarring in patients with severe aortic valve narrowing after valve replacement procedure
This trial focuses on patients with severe aortic stenosis and high levels of heart muscle scarring who will undergo TAVI. The study examines whether medications that fight tissue scarring can help reduce heart muscle scarring after the procedure.
Inclusion criteria: You must be 60 years or older, have severe symptomatic aortic stenosis, be scheduled for TAVI, be able to provide written informed consent, and can be either male or female.
Exclusion criteria: You cannot participate if you have a history of allergic reactions to spironolactone or dihydralazine, severe kidney problems (eGFR below 30 mL/min), high blood potassium levels (above 5.0 mmol/L), cannot undergo cardiac MRI, have contraindications to gadolinium contrast agents, are pregnant or breastfeeding, are in another trial, have mental conditions preventing informed consent, have life expectancy under one year, have severe liver disease, have uncontrolled high blood pressure (systolic above 160 mmHg), have known drug or alcohol abuse, or cannot follow study procedures or attend follow-up visits.
Focus and goals: The study lasts 12 months, during which patients take their assigned medications daily. To measure heart muscle scarring, patients undergo cardiac MRI using gadolinium contrast before their valve procedure and one year later. Some patients receive spironolactone alone, some receive both spironolactone and dihydralazine together, and others receive standard care without these additional medications.
Investigational treatment: Spironolactone is a medication that helps reduce fluid retention and works as an anti-fibrotic agent, potentially decreasing scarring in heart tissue. Dihydralazine is a blood pressure-lowering medication that relaxes blood vessels and may enhance anti-fibrotic effects when combined with spironolactone.
Study on Blood Thinners Apixaban, Edoxaban, Rivaroxaban, and Acetylsalicylic Acid for Patients with Aortic Stenosis After Heart Valve Replacement
This trial aims to find the best blood-thinning treatment after TAVI by comparing anticoagulants (apixaban, edoxaban, rivaroxaban) with acetylsalicylic acid (aspirin). These medications help prevent blood clots, which can be a concern after heart valve procedures.
Inclusion criteria: You must be between 65 and 80 years old, have had a successful TAVI procedure for aortic stenosis, have signed an informed consent form, and be expected to follow the study protocol.
Exclusion criteria: You cannot participate if you have a history of severe bleeding disorders, have had a recent stroke, have active infections, have severe kidney or liver disease, are in another trial, are pregnant or breastfeeding, have known allergies to the study medication, have uncontrolled high blood pressure, or have severe heart failure.
Focus and goals: The study lasts up to 12 months, during which participants take the assigned medication and attend regular follow-up visits. Researchers monitor health and side effects closely to assess the effectiveness of treatments in preventing complications such as blood clots and bleeding, and to evaluate safety by monitoring for adverse effects. The findings will help doctors make informed decisions about the best treatment options for patients with aortic stenosis who undergo TAVI.
Investigational treatment: The anticoagulants being tested (apixaban, edoxaban, rivaroxaban) help prevent blood clots by inhibiting certain proteins in the blood necessary for clotting. Acetylsalicylic acid (aspirin) prevents blood clots by stopping platelets from clumping together.
Summary
These 11 ongoing clinical trials represent diverse approaches to managing aortic stenosis and improving outcomes for patients undergoing valve replacement procedures. A notable concentration of trials is taking place in European countries, particularly Denmark and Germany, which each host multiple studies. The research focus spans several key areas: optimizing medication strategies before and after valve replacement procedures, investigating anti-fibrotic treatments to reduce heart muscle scarring, evaluating bleeding prevention protocols, and exploring medications originally developed for other conditions (such as SGLT2 inhibitors and angiotensin receptor blockers) for their potential benefits in aortic stenosis patients.
Many trials specifically target patients undergoing transcatheter aortic valve replacement, reflecting the growing importance of this minimally invasive procedure in modern cardiac care. Several studies examine familiar medications in new contexts, such as beta-blockers, antiplatelet agents, and blood thinners, seeking to determine optimal treatment regimens. Other trials investigate newer therapeutic approaches, including iron supplementation for patients with concurrent iron deficiency and advanced imaging techniques to understand inflammation’s role in post-procedure complications.
The variety of research approaches reflects the complexity of managing aortic stenosis and the ongoing effort to improve quality of life, reduce complications, and enhance recovery for patients living with this condition or undergoing treatment for it.
