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Study on Stopping Medication in Heart Failure Patients with Cardiac Resynchronization Therapy Using Eplerenone, Valsartan, and Bisoprolol Fumarate

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 stopping certain medications in patients with Heart Failure who have shown improvement after receiving a treatment called cardiac resynchronization therapy. The medications involved in this study include Eplerenone, Valsartan, Bisoprolol Fumarate, and Furosemide. These medications are commonly used to manage heart failure and related conditions. The purpose of the study is to understand what happens when these medications are withdrawn in patients whose heart function has improved.

Participants in the study will have their medications gradually reduced and monitored over a period of up to 12 months. During this time, doctors will closely observe any changes in heart function and overall health. The study aims to see if patients can maintain their improved heart function without the need for these medications. This will be done by checking heart function through imaging tests and monitoring for any signs of heart failure returning.

The study will also look at other health aspects, such as changes in blood pressure, heart rate, and quality of life. Participants will be asked to complete questionnaires about their daily life and well-being. The goal is to gather information that could help improve treatment strategies for heart failure patients in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include having received cardiac resynchronization therapy at least one year prior, with specific heart function measurements.

  2. Step 2

    Medication withdrawal

    The main objective of the study is to evaluate the effects of withdrawing certain medications. These medications include eplerenone, valsartan, bisoprolol fumarate, and furosemide.

    The withdrawal process is carefully monitored to observe any changes in heart function and overall health.

  3. Step 3

    Regular monitoring

    Regular monitoring is conducted throughout the study to track heart function and health status. This includes imaging tests and clinical evaluations.

    Participants are observed for any signs of heart function decline or other health issues.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are scheduled to evaluate the impact of medication withdrawal on heart function and quality of life.

    These assessments include imaging tests, blood pressure and heart rate measurements, and quality of life questionnaires.

  5. Step 5

    Study completion

    The study is expected to conclude by October 2025. Final assessments will be conducted to gather comprehensive data on the effects of medication withdrawal.

    Participants will receive a summary of their health status and any relevant findings from the study.

Who can join the trial?

9 criteria

  • Patients who have received cardiac resynchronization therapy (a treatment for heart failure) at least one year ago for a condition called left bundle branch block and had a left ventricular ejection fraction (LVEF) of less than 40% from non-ischemic origin (not caused by blocked arteries).
  • Current LVEF of 50% or higher and normal heart size in two separate heart ultrasound tests, done at least three months apart, with the last test done in the past six months.
  • Classified as NYHA functional class I-II, which means experiencing mild or no symptoms of heart failure during physical activity.
  • No hospital admissions for heart failure in the past year.
  • NT-proBNP levels (a blood test that helps diagnose heart failure) less than 450 pg/mL for patients with normal heart rhythm or less than 900 pg/mL for patients with atrial fibrillation (an irregular heart rhythm), in the past six months.
  • Currently taking medications such as beta-blockers, ACE inhibitors/ARA II/ARNI (types of heart medications) with or without ARM.
  • A normally functioning cardiac resynchronization therapy device with more than 95% pacing (the device is working properly).
  • Older than 18 years.
  • Patients who have given their written informed consent to participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have Heart Failure cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Cardiac Resynchronization Therapy (CRT) is a treatment for heart failure that uses a special type of pacemaker to make the heart's chambers pump in a more coordinated way. This therapy helps improve the heart's efficiency and can lead to better heart function and quality of life for patients with heart failure.

What is already known about the treatment

Cardiac Resynchronization Therapy (CRT) – This therapy is not a medication but a treatment involving a special type of pacemaker that helps the heart's chambers beat in sync, improving heart function. It is currently used in patients with heart failure, particularly those who have not responded well to other treatments. The main therapeutic indication for CRT is heart failure, where it helps improve the heart's pumping efficiency. At the molecular level, CRT does not involve a drug mechanism but rather electrical impulses that coordinate the heart's contractions. It falls under the category of device-based therapies rather than pharmacological treatments.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It often begins with the heart muscle weakening or becoming too stiff, which affects its ability to fill with and pump blood. As the condition progresses, fluid may build up in the lungs, liver, gastrointestinal tract, and extremities. Symptoms can include shortness of breath, fatigue, swollen legs, and rapid heartbeat. Over time, the heart's reduced efficiency can lead to further complications, such as arrhythmias or heart valve problems. The progression of heart failure can vary, with periods of stability followed by episodes of worsening symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504946-70-00Protocol codeIMIB-RMV-2021-02Estimated enrolment60 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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