Vasodilation or Loop-diuretics for Initial Treatment of Pulmonary Edema or Congestion Due to Acute Heart Failure A Randomized Placebo-controlled Trial

What this Trial Is About

Researchers are evaluating different urgent treatment strategies for pulmonary edema or congestion caused by acute heart failure. This trial aims to compare intravenous loop-diuretics (furosemide), vasodilation with nitrates (isosorbide dinitrate), and their combination to determine which approach is superior during emergency treatment. The study is randomized, double-blinded, and placebo-controlled, addressing an important gap due to limited data comparing these treatments in the hyperacute clinical setting. Participants will be randomly assigned to one of three groups receiving either boluses of 40 mg intravenous furosemide, boluses of 3 mg intravenous isosorbide dinitrate, or a combination of both drugs. These boluses will be given as soon as possible after hospital admission and may be repeated up to 10 times over a 6-hour intervention period based on the treating physician's discretion. The treatments start within 3 hours of hospital admission during initial in-hospital care. During the study, participants will be closely monitored for survival and hospital stay over 30 days, as well as therapy intensification events like mechanical ventilation or renal therapy. Researchers will also assess clinical benefit using a composite outcome, measure biomarker NT-proBNP levels, evaluate early warning scores, and record patient-reported breathlessness. Safety will be tracked through adverse events, with treatment adjustments if blood pressure drops or urine output is low. Total participation includes assessments during and after the 6-hour intervention and follow-up at 30 days.

Optimized Treatment of Pulmonary Edema or Congestion