Optimized Treatment of Pulmonary Edema or Congestion (NCT05276219) | Clinical Trial Compass
RecruitingPhase 4
Optimized Treatment of Pulmonary Edema or Congestion
Denmark1,104 participantsStarted 2023-09-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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) \*
Exclusion criteria
. More than 40 mg IV furosemide within the last three hours before randomization including prehospital treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.