RecruitingPhase 4NCT05276219

Optimized Treatment of Pulmonary Edema or Congestion

Vasodilation or Loop-diuretics for Initial Treatment of Pulmonary Edema or Congestion Due to Acute Heart Failure - a Randomized Placebo-controlled Trial


Sponsor

Rigshospitalet, Denmark

Enrollment

1,104 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Intravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission. Primary objective: To determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment. Design: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation. Intervention: Intervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups: * Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times. * Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible. * Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests different approaches to treating acute pulmonary edema — a serious condition where fluid builds up in the lungs, making it hard to breathe — to find the most effective treatment strategy in the emergency setting. **You may be eligible if...** - You are 18 or older - You have sudden onset or worsening shortness of breath - Your blood pressure is at or above 100 mmHg - Your blood oxygen is below 94% or you need supplemental oxygen - A doctor suspects fluid congestion in your lungs (based on symptoms or signs) **You may NOT be eligible if...** - You have already received more than 40 mg of IV furosemide (a water pill) in the last 3 hours - More than 3 hours have passed since you arrived at the hospital - You have a dangerous heart rhythm abnormality - You are suspected to have a severe infection or sepsis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFurosemide Injection

A diuretic (iv furosemide) strategy for decongestion in acute heart failure

DRUGIsosorbide Dinitrate

Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure

DRUGFurosemide and isosorbide dinitrate

Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure AND A diuretic (iv furosemide) strategy for decongestion in acute heart failure


Locations(4)

Bispebjerg Hospital

Copenhagen, Copenhagen, Denmark

Hvidovre Hospital

Copenhagen, Copenhagen, Denmark

Nordsjællands Hospital

Hillerød, Denmark

Roskilde Hospital

Roskilde, Denmark

View Full Details on ClinicalTrials.gov

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NCT05276219


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