Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Comparison of Furosemide, Nitrates, or Their Combination for Initial Treatment of Pulmonary Congestion in Patients with Acute Heart Failure

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

Acute heart failure with pulmonary congestion (fluid buildup in the lungs) causes breathing difficulties that develop suddenly or worsen over days. This study aims to determine the most effective emergency treatment strategy for this condition. The research compares three approaches: using only loop-diuretics (Furosemide), which help remove excess fluid through increased urination; using only vasodilation (nitrates), which relax blood vessels to reduce the workload on the heart; or using a combination of both medications.

Participants in the study will receive one of these treatment approaches or a placebo within three hours of hospital admission. The treatment will be administered when patients show symptoms like difficulty breathing, low oxygen levels, and signs of fluid buildup in the body. The study will monitor how patients respond to these different treatment strategies.

AI: I've provided a concise, patient-friendly description of the clinical trial about acute heart failure treatment. The description explains the condition being studied, the three treatment approaches being compared (loop diuretics, vasodilation, and combination therapy), and briefly outlines the study process without technical details. I've highlighted important medical terms and explained them in parentheses when they first appear. The text is written in simple language accessible to patients without medical training, avoiding direct address to the reader and maintaining an informational tone.

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

    Randomization and treatment assignment

    Upon joining the study, the patient will be randomly assigned to one of four treatment groups. This means that a computer system will decide which treatment the patient receives, similar to flipping a coin. The patient has an equal chance of receiving any of the following combinations:

    Group 1: Isoket (isosorbide dinitrate) and placebo instead of furosemide

    Group 2: Furosemide and placebo instead of Isoket

    Group 3: Both Isoket and furosemide

    Group 4: Two placebos (inactive substances that look like the real medications but contain no active ingredients)

  2. Step 2

    Emergency treatment phase

    Treatment will begin within 3 hours after hospital admission. The medications will be given through an injection or infusion (a slow injection into a vein).

    If assigned to receive Isoket, the patient will receive 30 mg of isosorbide dinitrate as an injectable solution. Isosorbide dinitrate is a medication that helps widen blood vessels, making it easier for the heart to pump blood.

    If assigned to receive furosemide, the patient will receive 400 mg of furosemide as an injection or infusion. Furosemide is a loop-diuretic, which is a type of medication that helps the body remove excess fluid through urination.

    If assigned to receive placebo, the patient will receive isotonic saline (salt water) that looks identical to the active medications but contains no active ingredients.

    The exact duration of this treatment phase is not specified in the study details, but it represents the initial emergency treatment period.

  3. Step 3

    Monitoring during hospital stay

    Between 6 to 24 hours after treatment starts, medical staff will measure the patient's Early Warning Score. This is a scoring system that helps healthcare providers assess how ill a patient is by checking vital signs like heart rate, blood pressure, breathing rate, and temperature.

    Between 12 to 24 hours after treatment starts, the patient will be asked to rate their breathing difficulty (called dyspnea) using a simple scale. The patient will describe whether breathing has improved, stayed the same, or worsened compared to when admitted to the hospital. The scale ranges from marked improvement to marked worsening.

    On days 1 to 3, medical staff will take a blood sample to measure NT-proBNP. This is a substance in the blood that indicates how well the heart is functioning. Higher levels suggest the heart is under more stress.

    Throughout the hospital stay, medical staff will monitor whether the patient needs additional or more intensive treatments, such as breathing support with a machine, kidney support treatments, medications to support blood pressure or heart function, or mechanical devices to help the heart.

  4. Step 4

    Follow-up until day 30

    The study team will track the patient's status for 30 days after treatment begins.

    The main measure of the study's success will be the number of days the patient is alive and not in the hospital during this 30-day period.

    The study team will also record whether the patient experiences any of the following events during the 30 days:

    Death from any cause

    Need for a breathing tube and mechanical ventilation (a machine that helps with breathing)

    Readmission to the hospital

    Any unwanted or harmful effects from the study medications will be documented as adverse events.

Who can join the trial?

5 criteria

  • Must be 18 years or older.
  • Must have a sudden or recent increase in difficulty breathing, known as acute dyspnea.
  • Must have a systolic blood pressure (the top number in a blood pressure reading) of 100 mmHg or higher.
  • Must have an oxygen saturation level of less than 94% or require oxygen support. Oxygen saturation is a measure of how much oxygen your blood is carrying.
  • Must show signs or have a suspicion of fluid buildup in the body, known as congestion. This can include swelling in the legs or feet (peripheral edema), crackling sounds in the lungs (rales), or other signs of fluid retention.

Who cannot join the trial?

9 criteria

  • Patients with **severe kidney problems** that require dialysis cannot participate. Dialysis is a treatment that does the work of your kidneys if they are not functioning well.
  • Patients who have had a **heart attack** in the last 30 days are not eligible. A heart attack happens when blood flow to the heart is blocked.
  • Patients with **severe liver disease** are excluded. The liver is an organ that helps digest food and remove toxins from the body.
  • Patients who are **pregnant or breastfeeding** cannot take part in the study.
  • Patients with **allergies to the study medications** (furosemide or nitrates) are not allowed to participate. Allergies are reactions that can cause symptoms like rash, swelling, or difficulty breathing.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with **uncontrolled high blood pressure** are excluded. High blood pressure is when the force of the blood against your artery walls is too high.
  • Patients with **severe lung disease** that affects breathing are not eligible.
  • Patients with **unstable mental health conditions** that might affect their ability to follow the study procedures are excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Furosemide is a medication used to help remove excess fluid from the body. It works by making the kidneys produce more urine, which helps reduce swelling and fluid buildup. In this trial, it is used to treat pulmonary congestion, which is a condition where fluid accumulates in the lungs, making it hard to breathe. By removing the extra fluid, furosemide can help improve breathing and reduce the strain on the heart.

Nitrates are medications that help widen blood vessels, which can improve blood flow and reduce the workload on the heart. In this trial, nitrates are used to treat pulmonary congestion by helping to lower the pressure in the blood vessels of the lungs. This can make it easier for the heart to pump blood and improve breathing in patients with acute heart failure.

The trial also explores the use of a combination of both Furosemide and Nitrates. This approach aims to provide the benefits of both medications: removing excess fluid with furosemide and improving blood flow with nitrates. The combination is tested to see if it offers better results in treating pulmonary congestion compared to using each medication alone.

What is already known about the treatment

  • Furosemide

    Furosemide is a medication administered orally or intravenously, commonly used to treat acute heart failure with pulmonary congestion. It is well-established in medical literature as a loop diuretic, which helps remove excess fluid from the body by increasing urine production. This action reduces the pressure on the heart and lungs, providing relief from symptoms like shortness of breath. Furosemide works by blocking the absorption of sodium and chloride in the kidneys, which leads to increased fluid excretion.

  • Nitrates

    Nitrates are typically administered orally or intravenously and are used in the treatment of acute heart failure with pulmonary congestion. They are recognized in medical literature as vasodilators, which means they help widen blood vessels, reducing the workload on the heart and improving blood flow. This action helps alleviate symptoms such as chest pain and shortness of breath. At the molecular level, nitrates release nitric oxide, which relaxes and dilates blood vessels, improving circulation and reducing heart strain.

Investigated diseases

Acute Heart Failure with Pulmonary Congestion – Acute heart failure with pulmonary congestion is a condition where the heart suddenly becomes unable to pump blood effectively, leading to a buildup of fluid in the lungs. This fluid accumulation causes difficulty breathing and can result in a sensation of suffocation. The condition often develops rapidly and can be triggered by factors such as heart attack, high blood pressure, or valve disorders. As the heart struggles to function, blood backs up into the lungs, causing increased pressure and fluid leakage into the lung tissue. This leads to symptoms such as shortness of breath, coughing, and wheezing. The progression of the disease can vary, but it typically requires immediate medical attention to manage the symptoms and underlying causes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500035-36-01Estimated enrolment1 041 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).