Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

Acute Heart Failure Clinical Trial

— REDOX-AHF  

Official title:

Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613218
• Other study ID #: REDOX
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Copenhagen University Hospital, Hvidovre
• Contact: Johannes Grand, MD, Phd
• Phone: +4535453545
• Email: johannes.grand[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: August 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure
• Hypoxemia
• Hypoxia
• Pulmonary Congestion

Intervention

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.

Locations

Country	Name	City	State
Denmark	Amager-Hvidovre Hospital	Copenhagen
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary parenchymal fluid content after 24 hours	Pulmonary parenchymal fluid content after 24 hours preceded by 10 minutes without oxygen-supplementation assessed noninvasively by the remote dielectric sensing (ReDS) device (Sensible Medical, Netanya, Israel)	24 hours
Secondary	All-cause mortality	Death from all causes	30 days
Secondary	Days alive out-of-hospital		30 days
Secondary	Time to freedom from oxygen-supplementation		48 hours
Secondary	4) Change from baseline in log-transformed biomarkers N-Terminal Pro-Brain Natriuretic Peptide to 24 hours from admission.		24 hours
Secondary	5) Arterial blood gas concentration after 24 hours preceded by 10 minutes without oxygen-supplementation.		24 hours
Secondary	Tricuspid annular plane systolic excursion		24 hours
Secondary	Global longitudinal strain of the right ventricle		24 hours