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Study of Risedronate Sodium for Patients with Dilated Cardiomyopathy Due to Troponin T Gene Mutation

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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 a heart condition known as dilated cardiomyopathy. This condition affects the heart's ability to pump blood efficiently because the heart's main pumping chamber, the left ventricle, becomes enlarged and weakened. In this study, researchers are investigating a specific cause of this condition, which is a change in the Troponin T gene due to a K210 deletion. The treatment being tested is a medication called Risedronate, which is usually taken as a 10 mg film-coated tablet. The purpose of the study is to see if taking Risedronate can improve heart function in patients with this specific genetic alteration.

Participants in the study will take Risedronate daily for a period of up to 12 months. Throughout the study, the heart's function will be monitored using an echocardiogram, which is a type of ultrasound that creates images of the heart. The main focus is to observe any changes in the heart's pumping ability over a six-month period. Additionally, the study will look at whether there is an improvement in the participants' ability to perform physical activities, which will be assessed through a stress test that measures oxygen consumption.

This trial aims to provide valuable insights into whether Risedronate can be an effective treatment for improving heart function in patients with dilated cardiomyopathy caused by the K210 deletion in the Troponin T gene. The study is expected to continue until mid-2026, with recruitment of participants starting in mid-2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria: being older than 18 years, having dilated cardiomyopathy due to a specific genetic mutation, and a left ventricular ejection fraction (LVEF) of 50% or less.

    Written informed consent is required before starting the trial.

  2. Step 2

    Medication administration

    The medication used in this trial is risedronate sodium, provided in the form of a film-coated tablet known as Actonel.

    The dosage is 10 mg per day, taken orally.

  3. Step 3

    Treatment duration

    The treatment with risedronate sodium is administered daily for a period of 6 months.

  4. Step 4

    Monitoring and assessments

    The primary goal is to observe any changes in left ventricular function, which will be measured using an echocardiogram at the end of the 6-month period.

    Secondary assessments include evaluating improvements in functional capacity through a stress test that measures oxygen consumption.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by July 31, 2026, with all assessments and data collection completed by this date.

Who can join the trial?

4 criteria

  • Must be **older than 18 years old**.
  • Have **dilated cardiomyopathy** due to a specific change in the **Troponin T gene** called the **K210 deletion mutation**. This means the heart muscle is weakened and enlarged because of a genetic change.
  • Have a **left ventricular ejection fraction (LVEF)** of **50% or less**. LVEF is a measure of how well the heart pumps blood with each beat.
  • Must have given **written informed consent**, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Patients who do not have dilated cardiomyopathy cannot participate. This is a condition where the heart becomes enlarged and cannot pump blood effectively.
  • Patients who do not have the specific K210 deletion mutation in the Troponin T gene cannot participate. This is a specific genetic change that affects a protein important for heart muscle function.
  • Patients who are not within the specified age range cannot participate. The age range includes certain age groups, but the exact ages are not specified here.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population are not automatically excluded, but specific criteria for vulnerability are not detailed here.
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Investigated drugs

Risedronate is a medication being studied for its potential effects on heart function in patients with a specific genetic mutation. This trial is investigating whether taking Risedronate can improve the heart's ability to pump blood in people with a condition called dilated cardiomyopathy, which is linked to a change in the Troponin T gene.

What is already known about the treatment

Risedronate – Risedronate is administered orally, typically in the form of tablets. It is currently being studied in clinical trials for its potential use in treating dilated cardiomyopathy, particularly in cases linked to a specific genetic mutation in the Troponin T gene. The main therapeutic indication under investigation is its effect on heart function, specifically the left ventricle, in patients with this condition. At the molecular level, Risedronate works by inhibiting bone resorption, which is primarily used in osteoporosis treatment, but its role in heart muscle function is being explored. It is classified pharmacologically as a bisphosphonate.

Investigated diseases

Dilated cardiomyopathy – Dilated cardiomyopathy is a condition where the heart's main pumping chamber, the left ventricle, becomes enlarged and weakened, leading to a decrease in its ability to pump blood effectively. Over time, this can cause the heart to become less efficient, resulting in symptoms such as fatigue, shortness of breath, and swelling in the legs and feet. The disease can progress gradually, with the heart muscle becoming increasingly stretched and thin. This condition can be caused by genetic mutations, infections, or other underlying health issues. As the heart's function declines, it may lead to complications affecting the body's ability to circulate blood properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509431-29-00Protocol codeIMIB-TRISMD-2023-02Estimated enrolment5 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

sourced from the EU Clinical Trials Register and site verification

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