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

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What is this study about?

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.

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Region Vaestmanland Vasteras Sweden

Other Sites

Site Name City Country Status
Danderyds Sjukhus AB Danderyd Sweden
Region Oestergoetland Linkoping Sweden
Region Oerebro Laen Orebro Sweden
Region Vaesterbotten Umea Sweden
Region Dalarna Falun Sweden
Kalthus Heart & Horse AB Lund Sweden
Region Skane Lasarettet I Landskrona Landskrona Sweden
Region Vaesternorrland Sundsvall Sweden
Region Soermland Nykoping Sweden
Region Uppsala Uppsala Sweden
Region Halland Varberg Sweden
Region Blekinge Karlskrona Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen Skovde Sweden
Sankt Gorans Sjukhus Stockholm Sweden
Region Joenkoepings Laen Jönköping Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Soedersjukhuset AB Stockholm Sweden
Rskzxx Ggtpqrx Visby Sweden
Rvttri Knmpuk Lkcp Kalmar Sweden
Rcyxwc Sopbyjlkb Stockholm Sweden
Rkuajf Vrixduhqr Karlstad Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not recruiting
27.11.2017

Trial locations

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.

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.

Trial ID:
2024-517448-79-00
NCT ID:
NCT02901184
Trial Phase:
Therapeutic confirmatory (Phase III)

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