Condition: Pulmonary Edema · Congestive Heart Failure · Acute Heart Failure · Sponsor: Rigshospitalet, Denmark
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.
This description comes directly from the study's public registry record.
Johannes Grand, MD, Phd, MPH · +4535452121 · johannes.grand@regionh.dk
Jens Jakob Thune, MD, PhD · jens.jakob.thune@regionh.dk
Always discuss trial participation with your own doctor first.
| Bispebjerg Hospital | Copenhagen, Copenhagen, Denmark | Recruiting |
| Hvidovre Hospital | Copenhagen, Copenhagen, Denmark | Recruiting |
| Nordsjællands Hospital | Hillerød, Denmark | Recruiting |
| Roskilde Hospital | Roskilde, Denmark | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05276219