Comparing oxygen levels in patients with acute heart failure and pulmonary congestion
Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
This study tests whether giving more or less oxygen helps people in the hospital with acute heart failure and fluid in their lungs feel better and recover faster.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT05613218 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two different oxygenation strategies in patients hospitalized with acute heart failure and pulmonary congestion. Participants will be randomly assigned to either a liberal oxygenation group, targeting an SpO2 of 96%, or a restrictive oxygenation group, targeting an SpO2 of 90%. The trial aims to determine which strategy leads to better clinical outcomes. The study will involve 122 patients and will utilize an oxygen-delivery robot to ensure concealed allocation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing acute heart failure with pulmonary congestion and require oxygen supplementation.
Not a fit: Patients with severe pulmonary disease or those who are suspected of having an infection or sepsis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with acute heart failure, potentially enhancing their recovery and outcomes.
How similar studies have performed: While there have been no prior clinical trials specifically investigating oxygen targets in acute heart failure, the approach of comparing oxygenation strategies is novel and untested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Acute (within minutes to days) onset or worsening of subjective dyspnea 3. Oxygen saturation \<92% (on arterial blood gas) or need of oxygen 4. At least one of the following clinical or radiological signs of congestion: 1. Pulmonary rales 2. Chest X-ray or CT with pulmonary congestion 3. Lung ultrasound with multiple B-lines Exclusion Criteria: 1. More than 4 hours from hospital admission to randomization 2. Suspected infection or sepsis 3. Known severe pulmonary disease 4. Systolic blood pressure \<90 mmHg
Where this trial is running
Copenhagen and 1 other locations
- Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
- Amager-Hvidovre Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Johannes Grand, MD, PhD — Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
- Study coordinator: Johannes Grand, MD, Phd
- Email: johannes.grand@regionh.dk
- Phone: +4535453545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.