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Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

NCT05613218 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Acute Heart Failure
  • Pulmonary Congestion
  • Hypoxemia

Interventions

DRUG

Oxygen

Patients will have nasal cannula or oxygen mask placed as the usual standard of care. Patients will be screened and randomized in the emergency department to either liberal or restrictive oxygenation after providing informed written consent and oxygen is titrated to the prespecified target range using an automated feedback device (O2MATIC). Consented patients will be randomly allocated to study groups via the web-based system within REDCap. The allocation will be concealed. Time at randomization will be considered as study time zero (T0). All patients will receive usual standard of care except for their O2 management. The intervention will last for 24 h. After 24 h, patients will be switched over to usual care for oxygen therapy. If the treating physician thinks, that the patient need another oxygenation target and it is thought to be harmful to continue with the allocated target, the intervention-phase can be stopped prematurely.

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Principal Investigators

  • Jens Hove, MD, PhD · Copenhagen University Hospital Amager-Hvidovre Department of Cardiology

  • Johannes Grand, MD, PhD · Copenhagen University Hospital Amager-Hvidovre Department of Cardiology

  • Ida Taraldsen, MD · Copenhagen University Hospital Amager-Hvidovre Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-02-02
Completion
2026-03-03

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613218 on ClinicalTrials.gov