Optimized Treatment of Pulmonary Edema or Congestion

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Edema, Congestive Heart Failure, Acute Heart Failure

In brief

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.

Key facts

Study ID

NCT05276219

Run by

Rigshospitalet, Denmark

People needed

1104

Starts

2023-09-14

Expected to finish

2027-05-31

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Acute (within minutes to days) onset or worsening of subjective dyspnea*
• Systolic blood pressure ≥100 mmHg
• Oxygen saturation <94% or need of oxygen
• Signs or suspicion of congestion (peripheral edema, rales, and/or clinical suspicion of congestion) *
• by the best assessment from a medical doctor. Inclusion must not wait on x-ray or other measures: patients suspected of pulmonary congestion should be included immediately.

You may not qualify if…

• More than 40 mg IV furosemide within the last three hours before randomization including prehospital treatment.
• More than 3 hours from hospital-admission to randomization
• Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR > 180 or < 40 bpm.
• Suspected severe infection or sepsis.
• Exclusion criteria are purposely liberal, so patients can be included in accordance with everyday clinical practice. However, a safety criterion will be implemented:
• If blood pressure drops below 90 mmHg in 2 measurements with 5 minutes apart and/or if urine production is below 50 ml after 1 hour, the intervention will be stopped, and patients can receive furosemide and nitrates freely.
• We purposely chose not to exclude patients with aortic stenosis, since observational studies did not find excess risk of given nitrates to patients with pulmonary edema and aortic stenosis

Where it is running

• Bispebjerg Hospital — Copenhagen, Copenhagen, Denmark (enrolling)
• Hvidovre Hospital — Copenhagen, Copenhagen, Denmark (enrolling)
• Nordsjællands Hospital — Hillerød, Denmark (enrolling)
• Roskilde Hospital — Roskilde, Denmark

Full record on ClinicalTrials.gov

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