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A study to compare continuous infusion and intermittent injections of furosemide and amiloride hydrochloride in patients hospitalized with acute heart failure and fluid overload

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Acute Heart Failure with volume overload, a condition where the heart cannot pump blood effectively, leading to an excess of fluid buildup in the body. The purpose of the study is to compare two different ways of giving the medication furosemide to see which method works better at removing extra fluid. Furosemide is a type of diuretic, which is a medication used to help the body get rid of extra salt and water through urination.

Participants in the study will receive the medication through an intravenous method, meaning it is delivered directly into a vein. One group will receive the drug through a bolus injection, which is a single, rapid dose given at specific times of the day. The other group will receive a continuous infusion, where the medication is delivered steadily over a period of time. This study aims to determine if the way the medicine is administered affects how well the body eliminates the excess fluid.

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

    Treatment assignment

    Participation in the study begins with the randomization process, which is a method used to assign treatment groups by chance.

  2. Step 2

    Medication administration

    The treatment involves the administration of furosemide, a medication used to help the body remove excess fluid. this is given through an intravenous infusion, which means the medicine is delivered directly into a vein.

  3. Step 3

    Comparison of delivery methods

    One group receives the medication as a continuous infusion, which is a steady flow of medicine over time, preceded by a loading dose to ensure an initial amount is in the system. the other group receives bolus injections, which are single, concentrated doses, three times a day.

  4. Step 4

    Monitoring and assessment

    The net weight loss is measured at 48 hours and 72 hours after the start of the treatment to track how much fluid is being removed from the body.

  5. Step 5

    Symptom evaluation

    The level of dyspnea, which is the medical term for shortness of breath, is assessed using a visual analogue scale at 72 hours after the start of the treatment.

Who can join the trial?

4 criteria

  • You must have a diagnosis of acute heart failure with volume overload, which means your heart is temporarily unable to pump enough blood, causing extra fluid to build up in your body.
  • You must show at least one sign of volume overload, such as swelling in your legs or fluid in your lungs.
  • You are expected to receive intravenous furosemide for at least 3 days. This is a type of medicine called a diuretic (a drug that helps your body get rid of extra water and salt through urine) that is given directly into a vein through a needle or tube.
  • You must be 18 years of age or older.

Who cannot join the trial?

8 criteria

  • You are experiencing shock, which is a life-threatening condition where the body does not get enough blood flow.
  • You need medications called inotropes or vasopressors, which are drugs used to help the heart pump stronger or to tighten blood vessels to increase blood pressure.
  • You are currently using or planning to use renal replacement therapy or ultrafiltration, which are medical treatments used to do the work of the kidneys, such as dialysis.
  • You have had a renal transplant, meaning you have received a transplanted kidney.
  • You are currently pregnant or breastfeeding.
  • You have severe hypokalaemia, which is a very low level of potassium (a mineral needed for muscles and nerves) in your blood.
  • You have severe hyponatremia, which is a very low level of sodium (a mineral that helps balance fluids) in your blood.
  • You have an allergy to furosemide or any of the ingredients used to make it.
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Investigated drugs

Furosemide is a medication used to help the body get rid of excess water and salt through urine. In this study, it is being tested to see if it works better when given as a steady drip into a vein or when given as separate quick injections several times a day to help patients with sudden heart failure.

What is already known about the treatment

  • Furosemide

    This medication is a widely used diuretic, often called a water pill, that is administered directly into a vein through an injection or a slow drip. It is primarily used to treat conditions like heart failure where the body holds onto too much fluid, helping to reduce swelling and ease the workload on the heart. At a molecular level, it works in the kidneys by blocking a specific protein that helps the body reabsorb salt, which causes more salt and water to be passed out of the body through urine. It is pharmacologically classified as a loop diuretic.

  • Amiloride hydrochloride

    This substance is a known medication typically used to help manage fluid levels in the body and is administered through a vein via injection or infusion. It is frequently used alongside other diuretics to treat conditions like heart failure by preventing the body from losing too much potassium while still helping to remove excess water. It works by blocking certain channels in the kidney cells that allow salt to be reabsorbed, thereby promoting the excretion of salt and water. It is pharmacologically classified as a potassium-sparing diuretic.

Investigated diseases

Acute heart failure with volume overload - This condition occurs when the heart cannot pump blood effectively enough to meet the body's needs. As a result, excess fluid begins to build up in the body's tissues and organs. This buildup often leads to swelling in the legs and accumulation of fluid in the lungs. The progression involves increasing pressure within the blood vessels. This pressure can make breathing more difficult as fluid enters the airways. The condition is characterized by this rapid accumulation of excess water and salt in the system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523589-26-00Protocol codeINFUSE-AHFEstimated enrolment436 patientsSponsorRegion Midtjylland

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