Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05613218
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2022-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Sponsor:
Copenhagen University Hospital, Hvidovre
Organization:
Study Overview
Official Title:
Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDOX-AHF
Brief 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.
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.
Detailed Description:
Background:
One million hospitalizations occur each year with a primary diagnosis of acute heart failure in the USA, with comparable numbers in Europe. Most patients with acute heart failure are treated with supplemental oxygen during hospitalization and guidelines recommend initiation of oxygen therapy if SpO2 \<90% (class I, level C). However, no clinical trials of oxygen targets in humans with acute heart failure investigating clinically relevant endpoints have been performed.
Primary objective:
To investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure.
Hypothesis:
Restrictive oxygenation is associated with improved clinical outcome compared to liberal oxygenation.
Design: Investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial.
Intervention:
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%.
Patients will have nasal cannula or oxygen mask placed as the usual care, and oxygen is titrated to the prespecified target range.
Consented patients will be randomly allocated to study groups via the automated 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 oxygen-administration.
The intervention-phase will be 24 h, and hereafter oxygen therapy will be at the discretion of the treating physician.
One million hospitalizations occur each year with a primary diagnosis of acute heart failure in the USA, with comparable numbers in Europe. Most patients with acute heart failure are treated with supplemental oxygen during hospitalization and guidelines recommend initiation of oxygen therapy if SpO2 \<90% (class I, level C). However, no clinical trials of oxygen targets in humans with acute heart failure investigating clinically relevant endpoints have been performed.
Primary objective:
To investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure.
Hypothesis:
Restrictive oxygenation is associated with improved clinical outcome compared to liberal oxygenation.
Design: Investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial.
Intervention:
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%.
Patients will have nasal cannula or oxygen mask placed as the usual care, and oxygen is titrated to the prespecified target range.
Consented patients will be randomly allocated to study groups via the automated 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 oxygen-administration.
The intervention-phase will be 24 h, and hereafter oxygen therapy will be at the discretion of the treating physician.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: