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Acute Heart Failure / Pulmonary Edema / Furosemide Injection · Phase 4 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 4, three-arm randomized controlled trial comparing loop diuretics (furosemide), vasodilation (isosorbide dinitrate), and combination therapy in acute heart failure with pulmonary edema at hospital admission. No results have been posted in the registry; the study is currently recruiting. The design addresses a stated clinical equipoise between established diuretic therapy and downgraded vasodilator recommendations due to lack of direct comparative evidence.
Phase 4, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Pulmonary Edema, Congestive Heart Failure, Acute Heart Failure; age from 18 Years. Intervention: Furosemide only; isosorbide dinitrate; isosorbide dinitrate + furosemide. Compared with: Three-arm comparison: furosemide monotherapy vs. isosorbide dinitrate monotherapy vs. combination therapy.. n = 1,041. 5 sites: Denmark.
This is a planned Phase 4, three-arm randomized controlled trial comparing loop diuretics (furosemide), vasodilation (isosorbide dinitrate), and combination therapy in acute heart failure with pulmonary edema at hospital admission. No results have been posted in the registry; the study is currently recruiting. The design addresses a stated clinical equipoise between established diuretic therapy and downgraded vasodilator recommendations due to lack of direct comparative evidence.
No effect sizes, safety data, or comparative efficacy information can be assessed from this record.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned Phase 4 study with no results yet posted; it documents study design and planned enrollment only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05276219). This is a study registration, not published results. Lead sponsor: Rigshospitalet, Denmark. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 1041 participants (ESTIMATED). Conditions: Pulmonary Edema, Congestive Heart Failure, Acute Heart Failure. Interventions: DRUG: Furosemide Injection; DRUG: Isosorbide Dinitrate; DRUG: Furosemide and isosorbide dinitrate. Primary outcome measures: Days alive and outside hospital , 30 days. Brief 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.
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