Not recruiting

Study of spironolactone and eplerenone in patients with heart failure with preserved ejection fraction (HFpEF)

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 study focuses on Heart Failure with Preserved Ejection Fraction, a condition where the heart's ability to pump blood remains normal, but the heart has trouble filling with blood between beats. The study examines the effectiveness of two medications: spironolactone and eplerenone, which are drugs that help manage fluid levels in the body and reduce strain on the heart.

The purpose of this research is to determine if adding either spironolactone or eplerenone to standard treatment helps reduce hospitalizations due to heart failure and prevents deaths from heart-related causes. The medications will be taken by mouth daily, with doses up to 50 milligrams, and the treatment period may last up to 120 days.

During the study, participants will receive either one of these medications along with their usual heart failure treatments, or continue with their usual treatments alone. The study uses a registry-based approach, which means it collects information about patients' health outcomes as part of their regular medical care.

The research process

The trial runs in 4 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 evaluated to confirm heart failure with preserved ejection fraction (a condition where the heart muscle pumps normally but doesn't fill with blood properly)
Your heart function measurement must show an ejection fraction of 40% or higher
A blood test will check for elevated levels of substances called natriuretic peptides that indicate heart stress
Step 2
Treatment assignment
You will be randomly assigned to one of two groups:
Group 1: Standard heart failure care plus either spironolactone or eplerenone (medications that help manage fluid levels)
Group 2: Standard heart failure care alone
Step 3
Medication schedule
If assigned to Group 1, you will take either spironolactone or eplerenone orally (by mouth) daily
All participants will continue taking their regular heart failure medications, including loop diuretics (water pills) daily or most days of the week
Step 4
Follow-up period
Your participation will continue until the study ends in December 2027
During this time, you will be monitored for any heart failure-related hospitalizations or heart-related health events

Who can join the trial?

9 criteria

Must provide written informed consent to participate in the study
Must be 50 years of age or older
Must have stable heart failure with symptoms and signs as determined by the doctor. Patients can join either as outpatients or while in hospital near discharge time
Must have a left ventricular ejection fraction of 40% or higher (this measures how well your heart pumps blood)
Must have elevated levels of natriuretic peptides (substances in blood that increase when heart fails) meeting one of these conditions:
- NT-proBNP above 300 ng/L (or BNP above 100 pg/mL) for patients with normal heart rhythm
- NT-proBNP above 750 ng/L (or BNP above 250 pg/mL) for patients with irregular heartbeat
- NT-proBNP above 1200 ng/L (or BNP above 400 pg/mL) within the past 12 months
- Must regularly use loop diuretics (water pills) daily or most days of the week
- Must have NYHA Class II-IV (classification of heart failure symptoms, ranging from mild to severe limitations in physical activity)

Who cannot join the trial?

15 criteria

Age below 18 years
Known allergic reaction to spironolactone or eplerenone
Currently using spironolactone or eplerenone
Severe kidney disease (where kidney function is significantly impaired)
High potassium levels in blood (hyperkalemia)
Severe liver disease
Pregnancy or planning to become pregnant
Currently breastfeeding
Systolic blood pressure below 90 mmHg (low blood pressure)
Taking other medications that can increase potassium levels
Participation in another clinical trial
Unable to provide informed consent
Life expectancy less than 12 months due to other medical conditions
Addison's disease (a condition where the body doesn't produce enough hormones)
History of serious side effects from similar medications

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Verified sites

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Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Soedersjukhuset AB
Responsive
Stockholm, Sweden

Trial locations

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Investigated drugs

Spironolactone A medication that belongs to a group of drugs called aldosterone antagonists. It helps manage heart failure by blocking a hormone called aldosterone, which can help reduce fluid retention and improve heart function. It's commonly used to treat heart failure and high blood pressure. Eplerenone Similar to spironolactone, this medication is also an aldosterone antagonist. It works by blocking hormones that can cause salt and fluid retention in the body. It's used to treat heart failure and high blood pressure, but may have fewer side effects compared to spironolactone. Standard of care This refers to the usual treatment that patients with heart failure with preserved ejection fraction (HFpEF) receive, which may include various medications and lifestyle modifications based on current medical guidelines.

What is already known about the treatment

Spironolactone
An oral medication that belongs to the class of potassium-sparing diuretics and acts as an aldosterone antagonist, commonly used in the treatment of heart failure with preserved ejection fraction (HFpEF). The medication works by blocking aldosterone receptors, which helps manage fluid retention and blood pressure while preserving potassium levels in the body. It is typically administered as a tablet once daily, with dosage adjusted based on individual patient response and laboratory monitoring.
Eplerenone
A selective aldosterone receptor antagonist taken orally as tablets, specifically designed to treat heart failure with preserved ejection fraction (HFpEF) with fewer hormonal side effects compared to spironolactone. The medication works by blocking mineralocorticoid receptors, helping to reduce fluid retention and improve heart function while maintaining potassium balance in the body. It is considered a newer generation medication in the same class as spironolactone and is typically prescribed as part of a comprehensive heart failure treatment plan.

Investigated diseases

Heart Failure with Preserved Ejection Fraction – A type of heart failure where the heart muscle contracts normally but doesn't relax properly between beats, reducing the amount of blood that can fill the heart chambers. The heart's pumping function remains normal, with an ejection fraction of 50% or higher, but it becomes stiff and less able to fill with blood during the relaxation phase. This condition typically develops gradually and becomes more common with age. Patients may experience symptoms such as shortness of breath, fatigue, and swelling in the legs. The condition often occurs alongside other health issues like high blood pressure, diabetes, or obesity.