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RECRUITING
NCT05276219
PHASE4

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

Sponsor: Copenhagen University Hospital, Rigshospitalet

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1041

Start Date

2023-09-14

Completion Date

2027-05-01

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

Furosemide Injection

A diuretic (iv furosemide) strategy for decongestion in acute heart failure

DRUG

Isosorbide Dinitrate

Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure

DRUG

Furosemide and isosorbide dinitrate

Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure AND A diuretic (iv furosemide) strategy for decongestion in acute heart failure

Locations (5)

Bispebjerg Hospital

Copenhagen, Copenhagen, Denmark

Herlev University Hospital

Herlev, Denmark

Nordsjællands Hospital

Hillerød, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Roskilde Hospital

Roskilde, Denmark