Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05276219

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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