Oxygen Targets in Acute Heart Failure With Pulmonary Congestion (NCT05613218) | Clinical Trial Compass
CompletedPhase 2/3
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Denmark122 participantsStarted 2024-02-01
Plain-language summary
This investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial will investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure with pulmonary congestion.
Patients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent.
1. Liberal oxygenation group = SpO2 target of 96%.
2. Restrictive oxygenation group = SpO2 target of 90%.
The allocation will be concealed through the use of an oxygen-delivery robot, termed O2MATIC. The study will include 122 patients.
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
. Oxygen saturation \<92% (on arterial blood gas) or need of oxygen
. At least one of the following clinical or radiological signs of congestion:
Exclusion criteria
. More than 4 hours from hospital admission to randomization
. Suspected infection or sepsis
. Known severe pulmonary disease
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.
1This trial tested specific oxygen targets in people with acute heart failure and pulmonary congestion — can you explain what 'oxygen targets' means in practice, and how the approach used here compares to how my oxygen levels would normally be managed if I'm admitted with a similar episode?
2The trial's main measurement was how much fluid remained in the lungs after 24 hours — did the results suggest that one oxygen strategy reduced lung fluid more effectively than the other, and what might that mean for how quickly someone could recover?
3Since this was a Phase 2/3 trial that has now completed, has enough safety and effectiveness data been published for you to consider this type of oxygen management approach in my care, or is it still too early to draw firm conclusions?
4Pulmonary congestion can vary a lot in severity — do you know whether the patients enrolled in this trial were similar to my situation, so we can judge whether the findings would likely apply to me?
5Are there standard treatment approaches for managing oxygen and fluid in acute heart failure that are already well established, and would you recommend trying those first before considering anything based on newer research like this trial?
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.
What they're measuring
1
Pulmonary parenchymal fluid content after 24 hours