Actively Recruiting
Optimized Treatment of Pulmonary Edema or Congestion
Led by Rigshospitalet, Denmark · Updated on 2026-04-22
1104
Participants Needed
4
Research Sites
193 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
Z
Zealand University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimized Treatment of Pulmonary Edema or Congestion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute onset or worsening of subjective shortness of breath within minutes to days
- Systolic blood pressure of 100 mmHg or higher
- Oxygen saturation below 94% or need for oxygen
- Signs or suspicion of fluid congestion such as peripheral edema, lung crackles, or clinical suspicion assessed by a doctor
You will not qualify if you...
- Received more than 40 mg IV furosemide within the last 3 hours before randomization
- More than 3 hours passed from hospital admission to randomization
- Ongoing ventricular tachycardia or bradycardia or supraventricular arrhythmias with heart rate over 180 or under 40 beats per minute
- Suspected severe infection or sepsis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Bispebjerg Hospital
Copenhagen, Copenhagen, Denmark, 2000
Actively Recruiting
2
Hvidovre Hospital
Copenhagen, Copenhagen, Denmark, 2650
Actively Recruiting
3
Nordsjællands Hospital
Hillerød, Denmark
Actively Recruiting
4
Roskilde Hospital
Roskilde, Denmark
Not Yet Recruiting
Research Team
J
Johannes Grand, MD, Phd, MPH
CONTACT
J
Jens Jakob Thune, MD, PhD
CONTACT
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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