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Taking people in DenmarkPhase 4

Comparing Two Medicines for Fluid Build-Up in Acute Heart Failure

Compares furosemide, isosorbide dinitrate, or both, in adults with heart failure fluid build-up.

Plain-language title generated from the registry record
Registry title: DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure

Key facts

Where
Copenhagen Nv, Herlev, Hilleroed, Hvidovre, Roskilde, and Slagelse, DenmarkSee the 6 sites
Phase
Phase 4

Where in Denmark

  • Bispebjerg HospitalCopenhagen Nv, DenmarkTaking people
  • Herlev HospitalHerlev, DenmarkTaking people
  • Hillerod HospitalHilleroed, DenmarkTaking people
  • Hvidovre University HospitalHvidovre, DenmarkTaking people
  • Roskilde HospitalRoskilde, DenmarkTaking people
  • Slagelse HospitalSlagelse, DenmarkTaking people

Questions to ask the study team

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  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Copenhagen University Hospital, Rigshospitalet
Trial code
NCT05276219EU 2022-500035-36-01
Record updated
23 October 2026
Original description
DECONGEST-AHF compares three initial treatments for adults admitted with suspected pulmonary congestion due to acute heart failure: intravenous furosemide, intravenous isosorbide dinitrate, or both medicines together. The aim is to determine which treatment gives patients the most days alive and outside hospital during the first 30 days.Read full original descriptionShow less

Vasodilatation or Loop-Diuretics for Initial Treatment of Pulmonary Congestion Due to Acute Heart Failure - A Randomized Placebo-Controlled Trial

DECONGEST-AHF compares three initial treatments for adults admitted with suspected pulmonary congestion due to acute heart failure: intravenous furosemide, intravenous isosorbide dinitrate, or both medicines together. The aim is to determine which treatment gives patients the most days alive and outside hospital during the first 30 days.

The trial is investigator-initiated, multicentre, randomised and blinded, with 1,041 participants allocated equally to three groups. During the first six hours, participants receive repeated boluses of 40 mg furosemide with nitrate placebo, 3 mg isosorbide dinitrate with furosemide placebo, or both active medicines. Doses are repeated at the treating physician's discretion within the protocol limits. Other usual care continues, and treatment may be stopped early if clinically required.

An embedded substudy will examine early clinical and haemodynamic responses in 79 participants from the main trial, using repeated bedside measurements during the first 360 minutes. The main trial treatment groups and primary outcome are unchanged.

Inclusion: 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.

Exclusion: Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR > 180 or < 40 bpm; Suspected severe infection or sepsis; More than 50 mg IV furosemide within the last three hours before randomization including prehospital treatment; More than 3 hours from hospital-admission to randomization; 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.

ClinicalTrials.gov NCT05276219 · EU CTIS 2022-500035-36-01