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Study of eplerenone in patients with heart failure and reduced ejection fraction who also have severe chronic kidney disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with two related conditions: heart failure with reduced ejection fraction and severe chronic kidney disease. These conditions occur when the heart cannot pump blood effectively and the kidneys are not functioning properly. The study will test a medication called eplerenone, which belongs to a group of drugs that help manage fluid levels and blood pressure in the body.

The purpose of this research is to evaluate if eplerenone can be safely used in patients who have both heart and kidney conditions, and to determine how well it works. The study will monitor how many patients can complete the treatment while maintaining safe levels of potassium in their blood. Some patients may need to take additional medication called a potassium binder during the study.

During this twelve-month study, participants will receive eplerenone through oral tablets. The medication dose will start at a lower amount and may be adjusted over time. Throughout the study, doctors will monitor various aspects of heart and kidney function, including blood tests and physical assessments. They will also track any changes in symptoms and overall health status.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your heart condition will be confirmed through medical records showing heart failure with reduced ejection fraction diagnosed at least 3 months ago
A heart scan (echocardiography) from the past 24 months must show your heart's pumping function is at 40% or less
Your kidney function test must show reduced function with specific measurements below normal range
Step 2
Treatment preparation
Your current heart failure medications must be stable for at least 4 weeks before starting the study
Your doctor will confirm you are in heart failure class II-III, which means you have mild to moderate limitations during physical activity
Step 3
Medication phase
You will receive eplerenone, a medication taken by mouth
Regular blood tests will monitor your kidney function and potassium levels
You may need additional medication to control potassium levels if necessary
Step 4
Monitoring and tests
You will complete a questionnaire about your heart failure symptoms
A walking test will measure how far you can walk in 6 minutes
Regular blood and urine tests will check your heart and kidney function
Your blood pressure will be monitored for any drops when standing up
Step 5
Safety monitoring
Your potassium levels will be closely monitored throughout the study
Any hospital visits related to your heart or kidney function will be recorded
You should report any feelings of dizziness when standing up
Any side effects you experience should be reported to the study team

Who can join the trial?

11 criteria

You must provide written consent to participate in the study
You must be at least 18 years old
You must have been diagnosed with heart failure with reduced ejection fraction (HFrEF) for at least 3 months before screening
You must have had an echocardiography (heart ultrasound) within the past 24 months showing an ejection fraction of 40% or less
You must have heart failure symptoms classified as New York Heart Association class II-III (mild to moderate limitations during physical activity)
Your heart failure treatment must be stable for at least 4 weeks before screening and include:
- Beta blockers
- SGLT2 inhibitors (diabetes medications that can help heart failure)
- ACE inhibitors or ARBs (blood pressure medications) if your kidney function allows
- If recommended by current guidelines, you must have appropriate heart devices installed (cardiac resynchronization therapy or implantable cardioverter-defibrillator)
- Your kidney function must show:
  - At least one measurement showing severe decrease (less than 30 ml/min/1.73m2) in the past 12 months
  - Current kidney function must be less than 45 ml/min/1.73m2

Who cannot join the trial?

12 criteria

Age below 18 years or above 75 years
Known allergic reactions to eplerenone or similar medications
High potassium levels in blood (above 5.0 mmol/L)
Severe liver disease affecting liver function
Currently receiving dialysis treatment
Pregnancy or breastfeeding
Uncontrolled high blood pressure (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
Recent heart attack or stroke (within last 3 months)
Taking certain medications that interact with eplerenone, such as strong CYP3A4 inhibitors (medications that affect how other drugs are processed in the body)
Participation in another clinical trial within the last 30 days
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to provide informed consent

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Danderyds Sjukhus AB
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Danderyd, Sweden

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Investigated drugs

Eplerenone is a medication that belongs to a class of drugs called mineralocorticoid receptor antagonists. It works by blocking the effects of a hormone called aldosterone, which can help reduce fluid retention and improve heart function. This medication is commonly used to treat heart failure and high blood pressure. In this trial, it is being studied specifically for patients who have heart failure with reduced ejection fraction (meaning their heart's ability to pump blood is reduced) and who also have severe kidney disease.

What is already known about the treatment

Eplerenone - A mineralocorticoid receptor antagonist medication that is taken orally in tablet form, primarily used to treat heart failure with reduced ejection fraction (HFrEF) and manage conditions involving excess aldosterone. The drug works by selectively blocking aldosterone receptors in the body, which helps regulate fluid balance, blood pressure, and cardiac function. Eplerenone belongs to the class of potassium-sparing diuretics and is particularly notable for its role in treating patients with both heart failure and kidney disease, though it requires careful monitoring in patients with severe kidney dysfunction. The medication has demonstrated significant benefits in reducing mortality and hospitalization rates in heart failure patients, as supported by numerous clinical trials and medical literature.

Investigated diseases

Heart Failure with Reduced Ejection Fraction
A condition where the heart muscle becomes weakened and cannot pump blood effectively, specifically when the heart's left ventricle squeezes less than normal. The heart's pumping capacity is reduced, typically pumping out less than 40% of its blood volume with each contraction. This leads to insufficient blood circulation throughout the body, causing fatigue and shortness of breath.
Chronic Kidney Disease
A gradual loss of kidney function that occurs over time, where the kidneys become damaged and cannot filter blood as well as they should. The condition causes a buildup of waste products and excess fluid in the body. The disease progresses through different stages, from mild damage to complete kidney failure. This condition often develops slowly over months or years, and may initially show few symptoms.