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VASODILATATION OR LOOP-DIURETICS FOR INITIAL TREATMENT OF PULMONARY CONGESTION DUE TO ACUTE HEART FAILURE – A RANDOMIZED PLACEBO-CONTROLLED TRIAL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500035-36-01
Enrollment
1104
Registered
2022-06-28
Start date
2023-09-14
Completion date
Unknown
Last updated
2025-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute heart failure with pulmonary congestion

Brief summary

Days alive and outside hospital until day 30

Detailed description

Intensification of therapy defineds as at least one of: mechanical ventilation, renal replacement therapy, vasopressors, inotropes, or mechanical heart failure treatment., Clinical benefit at 30 days, consisting of a composite of 1. All-cause death, 2. Intubation with mechanical ventilation, and 3. rehospitalization, , assessed using a ’win-ratio’ approach., NT-proBNP at day 1-3, Early Warning Score measured 6-24 hours after start of intervention, Adverse events, Patient-reported dyspnea assessment after 212--24 hours (7-point Likert scales in a standardized position: marked improvement from admission = 3, moderate improvement = 2, slight improvement = 1, no change = 0, slight worsening = -1, moderate worsening = -2, marked worsening = - 3

Interventions

DRUGIsoket
DRUGIsotonisk saltvand fremstillet af sygehusapoteket
DRUGFurosemide 10 mg/ml Solution for Injection or Infusion

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Days alive and outside hospital until day 30

Secondary

MeasureTime frame
Intensification of therapy defineds as at least one of: mechanical ventilation, renal replacement therapy, vasopressors, inotropes, or mechanical heart failure treatment., Clinical benefit at 30 days, consisting of a composite of 1. All-cause death, 2. Intubation with mechanical ventilation, and 3. rehospitalization, , assessed using a ’win-ratio’ approach., NT-proBNP at day 1-3, Early Warning Score measured 6-24 hours after start of intervention, Adverse events, Patient-reported dyspnea assessment after 212--24 hours (7-point Likert scales in a standardized position: marked improvement from admission = 3, moderate improvement = 2, slight improvement = 1, no change = 0, slight worsening = -1, moderate worsening = -2, marked worsening = - 3

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026