DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure

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 criteria 1. Age ≥ 18 years 2. Acute (within minutes to days) onset or worsening of subjective dyspnea\* 3. Systolic blood pressure ≥100 mmHg 4. Oxygen saturation \ 180 or \< 40 bpm. 4. Suspected severe infection or sepsis. Exclusion criteria are purposely liberal, so patients can be included in accordance with everyday clinical practice. However, a safety criterion will be implemented: 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