Optimized Treatment of Pulmonary Edema or Congestion

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Furosemide Injection
  • Isosorbide Dinitrate
  • Furosemide and isosorbide dinitrate

Treatment groups

1,104 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Rigshospitalet, Denmark

Lead sponsor

Hvidovre University Hospital

Sponsor institution

Zealand University Hospital

Collaborator

Copenhagen University Hospital, Hvidovre

Collaborator

Bispebjerg Hospital

Collaborator

Herlev Hospital

Collaborator