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Micronised Spironolactone

This article discusses two important clinical trials investigating the use of micronised spironolactone in different heart conditions. The SPIRRIT-HFpEF trial focuses on heart failure with preserved ejection fraction, while the SPONSoR study examines its potential in maintaining sinus rhythm in hypertensive patients with atrial fibrillation. These trials aim to evaluate the effectiveness and safety of spironolactone in improving cardiovascular outcomes and quality of life for patients with these conditions.

Table of Contents

What is Micronised Spironolactone?

Micronised Spironolactone is a medication that belongs to a class of drugs called mineralocorticoid receptor antagonists (MRAs). It’s a specially processed form of spironolactone, where the drug particles are made extremely small (micronised) to improve its absorption in the body. This medication is also known by the synonym “microfine spironolactone”[1].

Medical Conditions Treated

Micronised Spironolactone is used to treat several medical conditions, primarily related to heart and cardiovascular health. These include:

  • Heart Failure with Preserved Ejection Fraction (HFpEF): This is a condition where the heart muscle contracts normally but the ventricles don’t relax as they should, leading to heart failure symptoms[1].
  • Atrial Fibrillation (AF): An irregular and often rapid heart rate that can increase the risk of strokes, heart failure, and other heart-related complications[2].
  • Hypertension (High Blood Pressure): Spironolactone is often used as part of a treatment regimen for high blood pressure[2].

How It Works

Micronised Spironolactone works by blocking the effects of a hormone called aldosterone. Aldosterone causes the body to retain sodium and water while losing potassium. By blocking this hormone, spironolactone helps the body get rid of excess fluid while retaining potassium. This action can help lower blood pressure and reduce the workload on the heart[1][2].

Dosage and Administration

The dosage of Micronised Spironolactone can vary depending on the condition being treated and the individual patient’s needs. However, based on the clinical trials data:

  • For heart failure, doses may range from 25 mg to 50 mg daily[1].
  • For atrial fibrillation, a starting dose of 25 mg per day, which may be increased to a maximum of 50 mg per day, is being studied[2].

It’s important to note that the medication is typically taken orally and the dosage should always be determined by a healthcare professional[1][2].

Potential Benefits

Research suggests that Micronised Spironolactone may offer several potential benefits:

  • Reduction in heart failure hospitalizations and cardiovascular deaths in patients with HFpEF[1].
  • Maintenance of normal heart rhythm (sinus rhythm) in patients with atrial fibrillation[2].
  • Lowering of blood pressure in hypertensive patients[2].
  • Potential reduction in major cardiovascular events such as stroke and heart attack[2].

Side Effects and Safety

Like all medications, Micronised Spironolactone can cause side effects. Some potential side effects and safety considerations include:

  • Hyperkalemia: Elevated potassium levels in the blood. Regular blood tests are usually required to monitor potassium levels[1][2].
  • Kidney function changes: The medication can affect kidney function, particularly in people with pre-existing kidney problems[2].
  • Low blood pressure: Some patients may experience a drop in blood pressure[2].
  • Pregnancy and breastfeeding: Spironolactone is not recommended during pregnancy or while breastfeeding[2].

It’s crucial to discuss any potential side effects or safety concerns with your healthcare provider[1][2].

Ongoing Research

Micronised Spironolactone is currently being studied in several clinical trials to further understand its benefits and optimal use:

  • The SPIRRIT-HFpEF trial is investigating the use of spironolactone in patients with heart failure with preserved ejection fraction[1].
  • The SPONSoR study is examining the effectiveness of spironolactone in maintaining normal heart rhythm in patients with atrial fibrillation and high blood pressure[2].

These ongoing studies aim to provide more information about the long-term effects and benefits of Micronised Spironolactone in various cardiovascular conditions[1][2].

Aspect SPIRRIT-HFpEF Trial SPONSoR Study
Main Condition Heart failure with preserved ejection fraction Atrial fibrillation in hypertensive patients with preserved left ventricular ejection fraction
Primary Objective Reduce heart failure hospitalizations or cardiovascular death Reduce recurrence of atrial fibrillation episodes
Medication Studied Spironolactone or eplerenone Spironolactone
Dosage Not specified 25-50 mg daily
Study Duration Not specified 12 months
Key Inclusion Criteria Age ≥50, LVEF ≥40%, elevated natriuretic peptides, loop diuretic use Hypertension, paroxysmal or non-long-standing persistent AF, sinus rhythm at enrollment
Primary Endpoint Incidence rate of HF hospitalizations or CV death First documented recurrence of AF lasting ≥30 seconds

FAQ

  • What is the main purpose of the SPIRRIT-HFpEF trial? The main purpose of the SPIRRIT-HFpEF trial is to assess whether adding spironolactone or eplerenone to standard care can reduce the rate of heart failure hospitalizations or cardiovascular death in patients with heart failure with preserved ejection fraction (HFpEF).
  • What is the primary objective of the SPONSoR study? The primary objective of the SPONSoR study is to determine if adding spironolactone (25-50 mg daily) to standard therapy can reduce the recurrence of atrial fibrillation episodes within 12 months in hypertensive patients with preserved left ventricular ejection fraction.
  • Who is eligible to participate in the SPIRRIT-HFpEF trial? Eligible participants for the SPIRRIT-HFpEF trial include individuals aged 50 or older with stable heart failure, a left ventricular ejection fraction of 40% or higher, elevated natriuretic peptide levels, regular use of loop diuretics, and NYHA Class II-IV symptoms.
  • What are some of the exclusion criteria for the SPONSoR study? Some exclusion criteria for the SPONSoR study include contraindications to spironolactone therapy, acute or secondary atrial fibrillation, left atrium diameter greater than 60 mm, left ventricular ejection fraction less than 40%, and planned atrial fibrillation ablation within 6 months after randomization.
  • How is atrial fibrillation recurrence measured in the SPONSoR study? In the SPONSoR study, atrial fibrillation recurrence is measured as the first documented episode lasting at least 30 seconds, recorded either on a 12-lead ECG or using a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm, Withings) within 12 months of randomization.

Ongoing Clinical Trials on Micronised Spironolactone

  • Study of stopping heart failure medications in patients with non-ischemic cardiomyopathy who responded very well to cardiac resynchronization therapy

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

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

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on Spironolactone for Maintaining Sinus Rhythm in Hypertensive Patients with Atrial Fibrillation and Preserved Heart Function

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

Glossary

  • Heart failure with preserved ejection fraction (HFpEF): A type of heart failure where the heart's ability to pump blood is normal, but it has trouble filling with blood due to stiffness of the heart muscle.
  • Atrial fibrillation (AF): An irregular and often rapid heart rhythm that can lead to blood clots in the heart.
  • Left ventricular ejection fraction (LVEF): A measurement of how much blood the left ventricle pumps out with each contraction, used to assess heart function.
  • Spironolactone: A medication that belongs to a class of drugs called aldosterone antagonists, used to treat various heart and kidney conditions.
  • Eplerenone: Another aldosterone antagonist medication similar to spironolactone, used in treating certain heart conditions.
  • Natriuretic peptide: A hormone produced by the heart that helps regulate blood pressure and fluid balance, often used as a marker for heart failure.
  • NYHA Class: New York Heart Association classification system used to categorize the severity of heart failure symptoms.
  • Loop diuretics: A type of medication that increases urine production and helps remove excess fluid from the body, commonly used in heart failure treatment.
  • Cardiovascular (CV) death: Death caused by heart disease or blood vessel problems.
  • Sinus rhythm: The normal regular rhythm of the heart, controlled by the heart's natural pacemaker.

References

  1. http://clinicaltrials.eu/trial/study-on-spironolactone-and-eplerenone-for-patients-with-heart-failure-with-preserved-ejection-fraction/
  2. http://clinicaltrials.eu/trial/study-on-spironolactone-for-maintaining-sinus-rhythm-in-hypertensive-patients-with-atrial-fibrillation-and-preserved-heart-function/