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

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 the effects of a medication called spironolactone in patients with atrial fibrillation who also have high blood pressure and a normal functioning heart. Atrial fibrillation is a condition where the heart beats irregularly, and high blood pressure is when the force of the blood against the artery walls is too high. The study aims to see if adding spironolactone to the usual treatment can help reduce the recurrence of atrial fibrillation episodes over a period of 12 months.

Participants in the study will be randomly assigned to receive either spironolactone or a placebo, in addition to their standard treatment. The dosage of spironolactone will start at 25 mg per day and may be increased to a maximum of 50 mg per day. The study will last for 12 months, during which participants will have regular check-ups to monitor their heart rhythm and overall health. The goal is to determine if spironolactone can help maintain a normal heart rhythm and reduce the frequency of atrial fibrillation episodes.

Throughout the study, participants will be monitored for any side effects or changes in their condition. The study will also track other health outcomes, such as blood pressure levels and any major cardiovascular events. This research is important for understanding how spironolactone can be used to improve the management of atrial fibrillation in patients with high blood pressure.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, you will be required to sign a consent form, confirming your willingness to participate and comply with the study requirements.

    A pregnancy test will be conducted for women of childbearing age to ensure eligibility. Information on effective contraception methods will be provided.

  2. Step 2

    Initial assessment

    An initial health assessment will be conducted to confirm your current health status, including your blood pressure and heart rhythm.

    You will be required to have a smartphone (Android or iPhone) to participate in the study.

  3. Step 3

    Medication administration

    You will begin taking spironolactone in the form of a tablet. The initial dosage will be 25 mg per day, taken orally.

    The dosage may be increased to a maximum of 50 mg per day, based on your response to the medication.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits will occur at 1, 6, and 12 months after starting the medication.

    During these visits, your blood pressure and heart rhythm will be assessed, and any side effects will be monitored.

  5. Step 5

    Monitoring

    You will be provided with a wearable device to monitor your heart rhythm continuously. This device will help track any episodes of irregular heartbeats.

    The device will record data that will be reviewed by the study team to assess the effectiveness of the treatment.

  6. Step 6

    Completion

    The study will conclude 12 months after your enrollment. A final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

    You will be informed of the study results and any further recommendations for your health management.

Who can join the trial?

10 criteria

  • Must be male or female. Women who can have children must take a pregnancy test and use effective birth control during the study.
  • Must be part of the social security system.
  • Must be 18 years or older.
  • Must have high blood pressure and have been taking medication for it for more than 12 months.
  • Must have had at least one episode of atrial fibrillation (AF) in the last 12 months. AF is a condition where the heart beats irregularly.
  • Must have a normal heart rhythm at the time of joining the study.
  • Must own a smartphone (Android or iPhone).
  • Must have signed consent to participate in the study.
  • Must be willing to attend scheduled visits as required by the study.
  • Must be able to speak French.

Who cannot join the trial?

5 criteria

  • Patients who do not have atrial fibrillation (a type of irregular heartbeat) with a preserved left ventricular ejection fraction (a measure of how well the heart pumps blood).
  • Patients who are not taking standard therapy for their condition.
  • Patients who are unable to take spironolactone (a medication used to treat certain heart conditions).
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population (groups that may need special protection).
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Investigated drugs

Spironolactone is a medication used in this clinical trial to help maintain a normal heart rhythm in patients with high blood pressure and a specific type of heart condition. It works by blocking certain hormones in the body that can cause fluid retention and affect heart function. In this study, spironolactone is being tested to see if it can reduce the number of times patients experience irregular heartbeats over a year, when added to their usual treatment. The goal is to see if it can help keep the heart beating regularly and improve overall heart health.

What is already known about the treatment

Spironolactone – Spironolactone is taken orally in pill form and is currently being studied for its effectiveness in maintaining normal heart rhythm in patients with high blood pressure and a specific type of heart condition called atrial fibrillation, where the heart's upper chambers beat irregularly. It is already used in medicine for other conditions, but this study aims to see if it can help reduce episodes of irregular heartbeats when added to standard treatments. Spironolactone works by blocking certain hormones that can affect heart and blood vessel function, helping to maintain a stable heart rhythm. It is classified as a diuretic, which means it helps the body get rid of excess salt and water, but in this context, it is being explored for its potential heart rhythm benefits.

Investigated diseases

Atrial Fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) experience chaotic electrical signals, causing them to quiver instead of contracting effectively. This can lead to poor blood flow and may cause symptoms such as palpitations, fatigue, and shortness of breath. Over time, atrial fibrillation can contribute to the formation of blood clots in the heart, which can travel to other parts of the body. The condition can vary in frequency and duration, with episodes lasting from minutes to hours or becoming persistent. It is often associated with other heart-related conditions, such as high blood pressure or heart disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518146-25-00Protocol code20-197Estimated enrolment580 patientsSponsorCentre Hospitalier Universitaire De Caen Normandie

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