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Study on Acetazolamide with Empagliflozin and Dapagliflozin for Patients with Acute Heart Failure and Fluid Retention

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 combining the medication Acetazolamide with a group of medications known as SGLT2 inhibitors in patients who have Acute Heart Failure and are experiencing volume overload. Volume overload occurs when there is too much fluid in the body, which can be a common issue in heart failure. The medications being tested include Jardiance (containing empagliflozin), Forxiga (containing dapagliflozin), and DIAMOX (containing acetazolamide). These medications are being studied to see if they can help improve the removal of excess sodium and fluid from the body.

The purpose of the study is to see if this combination of medications can improve the process of natriuresis, which is the body's ability to excrete sodium through urine. Participants in the study will receive these medications and their effects will be monitored over a period of time. The study will look at how much sodium is excreted in 24 hours, as well as other factors like changes in body weight, fluid levels, and certain hormones in the blood. The study will also use imaging techniques to assess changes in the heart and other areas of the body.

Participants will be monitored for changes in their condition, including how much fluid they lose and any changes in their symptoms. The study aims to provide more information on how these medications can be used together to help manage symptoms of acute heart failure and improve patient outcomes. The trial is expected to run until the end of 2025, with recruitment starting in early 2024.

The research process

The trial runs in 4 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 verifying age (18 years or older), diagnosis of heart failure, and current treatment with loop diuretics of at least 40 mg of furosemide or its equivalent.

    The treating cardiologist assesses the presence of volume overload to determine the need for additional therapy with SGLT2 inhibitors and intravenous loop diuretics.

  2. Step 2

    Medication administration

    Participants receive a combination of medications to manage heart failure and volume overload. This includes Jardiance (empagliflozin) 10 mg film-coated tablets and Forxiga (dapagliflozin) 10 mg film-coated tablets, both taken orally.

    Additionally, DIAMOX (acetazolamide) is administered as a 500 mg powder for solution, given intravenously. The specific dosage and frequency are determined by the study protocol and the treating physician.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, participants undergo regular monitoring to evaluate the effectiveness of the treatment. This includes measuring 24-hour sodium excretion as the primary endpoint.

    Secondary endpoints include assessments of 24-hour volume output, weight changes, and congestion according to the ADVOR protocol. Additional evaluations involve plasma volume changes, neurohormonal stimulation (renin, aldosterone), and changes observed through POCUS (heart, IVC, lung, abdomen, JVP).

  4. Step 4

    Trial completion

    The trial is expected to continue until December 31, 2025. Participants will be informed of their progress and any relevant findings throughout the study period.

    Upon completion, participants may receive a summary of the study results and any implications for their ongoing treatment.

Who can join the trial?

4 criteria

  • Must be 18 years or older.
  • Must have Heart Failure, which is a condition where the heart doesn't pump blood as well as it should.
  • Must be on a regular treatment with loop diuretics of at least 40mg of furosemide or similar. Loop diuretics are medications that help remove excess fluid from the body.
  • Must be considered to have too much fluid in the body by the heart doctor, which requires adding a medication called SGLT2i and an IV loop diuretic therapy. SGLT2i is a type of medication that helps the body get rid of extra sugar and water through urine. IV loop diuretic therapy is a treatment given through a vein to help remove excess fluid.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent heart attack or stroke.
  • Patients with severe kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients with a known allergy to the study medication.
  • Patients who have a history of drug or alcohol abuse.
  • Patients with uncontrolled high blood pressure.
  • Patients who have had a major surgery within the last month.
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Investigated drugs

  • Acetazolamide

    is a medication used to help remove excess fluid from the body. It works by increasing the amount of urine produced, which helps reduce fluid buildup. In this trial, it is being tested to see if it can help patients with acute heart failure who have too much fluid in their bodies.

  • SGLT2 Inhibitors

    are a type of medication that helps lower blood sugar levels in people with diabetes. They work by helping the kidneys remove sugar from the body through urine. In this trial, they are being used in combination with acetazolamide to see if they can help improve fluid removal in patients with acute heart failure.

What is already known about the treatment

Acetazolamide – Acetazolamide is typically administered orally or intravenously. It is currently being studied in combination with SGLT2 inhibitors for its potential benefits in patients experiencing volume overload and acute heart failure. The main therapeutic indication for acetazolamide in this context is to enhance natriuresis, which is the excretion of sodium in the urine. At the molecular level, acetazolamide works by inhibiting the enzyme carbonic anhydrase, which leads to increased excretion of bicarbonate, sodium, and water, thereby reducing fluid overload. It is classified pharmacologically as a carbonic anhydrase inhibitor.

Investigated diseases

Acute Heart Failure – This condition occurs when the heart suddenly becomes unable to pump blood effectively, leading to a rapid buildup of fluid in the lungs and other parts of the body. It can result from various causes, such as a heart attack, severe high blood pressure, or valve disorders. Symptoms often include sudden shortness of breath, swelling in the legs and feet, and fatigue. The heart's reduced ability to pump blood can lead to congestion in the lungs, causing difficulty breathing. As the condition progresses, it may affect the kidneys and other organs due to inadequate blood flow. Monitoring and managing fluid levels in the body is crucial to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513799-16-00Estimated enrolment30 patientsSponsorZiekenhuis Oost Limburg

sourced from the EU Clinical Trials Register and site verification

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