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

NCT05276219 · tracked via the Priya Life Science Denmark tracker

Sponsor

Copenhagen University Hospital, Rigshospitalet

Phase

Phase 4

Started

2023-09-14

Last updated

2026-08-17

Condition(s) studied

Pulmonary EdemaCongestive Heart FailureAcute Heart Failure

Investigational drug(s) / intervention(s)

Furosemide Injection →Isosorbide DinitrateFurosemide and isosorbide dinitrate

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

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 \<94% or need of oxygen 5. 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 criteria 1. More than 50 mg IV furosemide within the last three hours before randomization including prehospital treatment. 2. More than 3 hours from hospital-admission to randomization 3. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 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

Primary outcome measure(s)

Days alive and outside hospital — 30 days
The number of days during the 30-day period after the index emergency-department visit that the participant is alive and outside hospital. The outcome captures mortality, duration of the index admission and subsequent hospital readmissions. A return visit to an emergency department is counted as one hospital day.

Trial sites (5)

Facility	City	Region	Status
Bispebjerg Hospital	Copenhagen	Copenhagen	Recruiting
Hvidovre Hospital	Copenhagen	Copenhagen	Recruiting
Herlev University Hospital	Herlev	Denmark	Recruiting
Nordsjællands Hospital	Hillerød	Denmark	Active Not Recruiting
Roskilde Hospital	Roskilde	Denmark	Not Yet Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05276219 on ClinicalTrials.gov ↗ ← All trials in Denmark