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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country
Slagelse Hospital	Slagelse	Denmark
Zealand University Hospital	Koege	Denmark
Hcweak Hwquzjbp	Herlev	Denmark
Hriyyrni Hifsxawo	Hvidovre	Denmark
Hdewrpdf Hrjaibqt	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2023

Trial locations

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.

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 ID:

2022-500035-36-01

NCT ID:

NCT05276219

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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