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

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying heart failure, a condition where the heart doesn't pump blood as well as it should. The study aims to compare two treatments: spironolactone and eplerenone. Both of these medications are known as aldosterone antagonists, which help the body get rid of excess salt and water, reducing the workload on the heart.

The purpose of the study is to see how effective these two medications are in reducing the risk of death in patients with heart failure who have a reduced ejection fraction. Ejection fraction is a measurement of how much blood the left ventricle of the heart pumps out with each contraction. Patients participating in the study will be monitored over a period of time to observe the effects of the medications on their heart health.

During the study, participants will receive either spironolactone, eplerenone, or a placebo. The study will track the occurrence of death or hospitalization due to heart failure as key outcomes. This research will help determine if spironolactone and eplerenone are comparable in their effectiveness for treating heart failure. The study is expected to continue until the end of 2028.

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
Joining the trial
Upon joining the study, you will be registered as a participant in the clinical trial called CROWD-ASPECT. This trial is designed to compare the effectiveness of two medications, spironolactone and eplerenone, in treating heart failure with reduced ejection fraction.
Step 2
Medication assignment
You will be assigned to receive either spironolactone or eplerenone. Both medications are taken orally in the form of film-coated tablets. The specific dosage and frequency will be determined by the study team based on your individual health needs.
Step 3
Medication administration
You will take the assigned medication as directed by the study team. It is important to follow the prescribed dosage and schedule to ensure the accuracy of the trial results.
Step 4
Regular follow-up
Throughout the trial, you will have regular follow-up appointments at the heart failure clinic. These appointments are crucial for monitoring your health and the effectiveness of the medication.
Step 5
End of trial
The trial is expected to conclude by December 31, 2028. At the end of the trial, the study team will analyze the data to determine the effectiveness of the medications in reducing the risk of death and hospitalization due to heart failure.

Who can join the trial?

5 criteria

Patients must be registered in the Danish Heart Failure Registry.
Patients must have a condition called reduced ejection fraction, which means the heart is not pumping as well as it should.
Patients must have filled at least one prescription for a type of medication called an aldosterone antagonist, which is used to treat heart failure.
Both men and women can participate.
Participants should be adults, as the age range includes categories 3 and 4, which typically refer to adults.

Who cannot join the trial?

4 criteria

Patients with a history of **heart failure** cannot participate. Heart failure is a condition where the heart does not pump blood as well as it should.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not eligible for treatment with **aldosterone antagonists** cannot participate. Aldosterone antagonists are medications used to treat heart failure by blocking certain hormones that can cause heart problems.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Bispebjerg Hospital
Copenhagen, Denmark

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Investigated drugs

Spironolactone
is a medication used to help people with heart failure. It works by blocking a hormone in your body called aldosterone, which can cause your body to hold onto too much salt and water. By blocking this hormone, spironolactone helps your body get rid of the extra salt and water, which can reduce the strain on your heart and help it work better. This medication is being studied to see how well it helps people with heart failure live longer.
Eplerenone
is another medication used for treating heart failure. Like spironolactone, it also blocks the hormone aldosterone, helping your body remove excess salt and water. This can help reduce the workload on your heart and improve its function. The study is looking at how effective eplerenone is in helping people with heart failure compared to spironolactone, especially in terms of reducing the risk of death.

What is already known about the treatment

Spironolactone
Spironolactone is a medication taken orally, usually in the form of a tablet. It is currently used in medicine to help manage heart failure, particularly in patients with reduced ejection fraction, and is well-documented in medical literature. The main therapeutic use of spironolactone is to reduce the risk of death in heart failure patients by acting as an aldosterone antagonist. At the molecular level, it works by blocking the effects of aldosterone, a hormone that can cause the body to retain salt and water, leading to increased blood pressure and strain on the heart. Spironolactone is classified as a potassium-sparing diuretic, which means it helps the body get rid of excess fluid without losing potassium.
Eplerenone
Eplerenone is administered orally, typically in tablet form, and is used in the medical field to treat heart failure, especially in patients with reduced ejection fraction. It is recognized in medical literature for its role in reducing the risk of death in these patients. Eplerenone works by blocking the action of aldosterone, a hormone that can lead to fluid retention and increased blood pressure, thereby reducing the workload on the heart. It is classified as a selective aldosterone receptor antagonist, which helps manage fluid balance and blood pressure without causing significant potassium loss.

Investigated diseases

Heart failure – Heart failure is a chronic condition where the heart is unable to pump blood effectively to meet the body's needs. It often results from damage to the heart muscle, such as from a heart attack or high blood pressure. As the condition progresses, the heart becomes weaker, leading to symptoms like fatigue, shortness of breath, and fluid retention. Over time, the heart's reduced ability to pump blood can cause congestion in the lungs and other parts of the body. This can lead to swelling in the legs and abdomen, as well as difficulty breathing, especially when lying down. The progression of heart failure can vary, with periods of stability followed by episodes of worsening symptoms.