REDOX-AHF: Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

Sponsor

Copenhagen University Hospital, Hvidovre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05613218

Collaborator

Bispebjerg Hospital (Other)

122

Enrollment

Location

Arms

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Liberal oxygenation group = SpO2 target of 96%.
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.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure Pulmonary Congestion Hypoxemia	Drug: Oxygen	Phase 2/Phase 3

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.

Liberal oxygenation group = SpO2 target of 96%.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 allocation1:1 allocation

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Oxygen-delivery will be given through a robot, which adjusts oxygen-flow towards a given oxygen-saturation target. The robots monitor will be turned of during the intervention and will only alarm in case of clinically relevant hypoxemia.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liberal oxygenation group SpO2 target of 96%	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.
Active Comparator: Restrictive oxygenation group SpO2 target of 90%.	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.

Arm

Intervention/Treatment

Active Comparator: Liberal oxygenation group

SpO2 target of 96%

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.

Active Comparator: Restrictive oxygenation group

SpO2 target of 90%.

Drug: Oxygen

Outcome Measures

Primary Outcome Measures

Pulmonary parenchymal fluid content after 24 hours [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)

Secondary Outcome Measures

All-cause mortality [30 days]
Death from all causes
Days alive out-of-hospital [30 days]
Time to freedom from oxygen-supplementation [48 hours]
4) Change from baseline in log-transformed biomarkers N-Terminal Pro-Brain Natriuretic Peptide to 24 hours from admission. [24 hours]
5) Arterial blood gas concentration after 24 hours preceded by 10 minutes without oxygen-supplementation. [24 hours]
Tricuspid annular plane systolic excursion [24 hours]
Global longitudinal strain of the right ventricle [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:
Pulmonary rales 2. Chest X-ray or CT with pulmonary congestion 3. Lung ultrasound with multiple B-lines

Exclusion Criteria:

More than 4 hours from hospital admission to randomization
Suspected infection or sepsis
Known severe pulmonary disease
Systolic blood pressure <90 mmHg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg Hospital	Copenhagen		Denmark	2200

Sponsors and Collaborators

Copenhagen University Hospital, Hvidovre
Bispebjerg Hospital

Investigators

Study Chair: Jens Hove, MD, PhD, Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
Principal Investigator: Johannes Grand, MD, PhD, Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
Study Director: Ida Taraldsen, MD, Copenhagen University Hospital Amager-Hvidovre Department of Cardiology