NCT05276219RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Vasodilatation or Loop-Diuretics for Initial Treatment of Pulmonary Congestion Due to Acute Heart Failure - A Randomized Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1041 (estimated)
- First submitted
- 31 Jan 2022
- Start date
- 14 Sept 2023
- Primary completion date
- 1 May 2027
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Heart failure
- NCT number
- NCT05276219
- EU CT number
- 2022-500035-36-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1041
- From 14 Sept 2023 to the primary completion date, 1 May 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm.
- Suspected severe infection or sepsis.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Hillerod Hospital Coordinator of this site? Confirm its status | Hilleroed | Denmark | Recruiting |
| Hvidovre University Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Roskilde Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Slagelse Hospital Coordinator of this site? Confirm its status | Slagelse | Denmark | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.