Optimized Treatment of Pulmonary Edema or Congestion
Status:
Not yet recruiting
Trial end date:
2025-08-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Johannes Grand
Collaborators:
Bispebjerg Hospital Copenhagen University Hospital, Hvidovre Zealand University Hospital