Comparing IV Furosemide, IV Isosorbide Dinitrate, and Their Combination for Emergency Treatment of Pulmonary Edema in Acute Heart Failure
Led by Rigshospitalet, Denmark · Updated on 2026-04-22
1104
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating different urgent treatment strategies for pulmonary edema or congestion caused by acute heart failure. This trial aims to compare intravenous loop-diuretics furosemide, vasodilation with nitrates isosorbide dinitrate, and their combination to determine which approach is superior during emergency treatment. The study is randomized, double-blinded, and placebo-controlled, addressing an important gap due to limited data comparing these treatments in the hyperacute clinical setting.
Participants will be randomly assigned to one of three groups receiving either boluses of 40 mg intravenous furosemide, boluses of 3 mg intravenous isosorbide dinitrate, or a combination of both drugs. These boluses will be given as soon as possible after hospital admission and may be repeated up to 10 times over a 6-hour intervention period based on the treating physicians discretion. The treatments start within 3 hours of hospital admission during initial in-hospital care.
During the study, participants will be closely monitored for survival and hospital stay over 30 days, as well as therapy intensification events like mechanical ventilation or renal therapy. Researchers will also assess clinical benefit using a composite outcome, measure biomarker NT-proBNP levels, evaluate early warning scores, and record patient-reported breathlessness. Safety will be tracked through adverse events, with treatment adjustments if blood pressure drops or urine output is low. Total participation includes assessments during and after the 6-hour intervention and follow-up at 30 days.
CONDITIONS
Brief Title
Optimized Treatment of Pulmonary Edema or Congestion
Research Team
J
Johannes Grand, MD, Phd, MPH
J
Jens Jakob Thune, MD, PhD
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Acute onset or worsening of subjective shortness of breath within minutes to days
Systolic blood pressure of at least 100 mmHg
Oxygen saturation below 94% or need for oxygen
Signs or suspicion of congestion such as peripheral edema or rales, assessed by a medical doctor
Inclusion should not be delayed pending x-ray or other tests if congestion is suspected
You will not qualify if you...
Received more than 40 mg intravenous furosemide within the last 3 hours before randomization
More than 3 hours elapsed from hospital admission to randomization
Ongoing ventricular tachycardia or bradycardia, or supraventricular arrhythmias with heart rate over 180 or below 40 bpm
Suspected severe infection or sepsis
Intervention stopped if blood pressure falls below 90 mmHg in two measurements 5 minutes apart or urine output is below 50 ml after 1 hour
Patients with aortic stenosis are not excluded
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Treatment
Duration - Initial treatment during the first 6 hours in hospital
Participants receive one of three intravenous drug treatments for pulmonary edema: furosemide alone, isosorbide dinitrate alone, or a combination of both. Treatment starts within 3 hours after hospital admission and involves boluses repeated up to 10 times as determined by the treating physician.
Treatment visits during hospital stay as needed for medication administration
Follow-up
Duration - 30 days
Participants are monitored for clinical outcomes, adverse events, and other health assessments up to 30 days after treatment.
Follow-up visits or assessments conducted up to 30 days after treatment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Vasodilation, loop diuretics, or their combination in acute heart failure: Rationale and design of the randomized placebo-controlled DECONGEST-AHF trial.
Anne Sophie Overgaard Olesen, Jasmin Dam Lukoschewitz, Ida Arentz Taraldsen...