Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

NCT05613218 | Recruiting Phase 2

• 1 other identifier: REDOX
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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. 1.Liberal oxygenation group = SpO2 target of 96%.
2. 2.Restrictive oxygenation group = SpO2 target of 90%.

Conditions

Acute Heart Failure; Pulmonary Congestion; Hypoxemia

Keywords

acute heart failure; Pulmonary edema; Oxygen; Pulmonary congestion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• All-cause mortality

  30 days

• 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

Study Arms (2)

Liberal oxygenation group

ACTIVE COMPARATOR

SpO2 target of 96%

Drug: Oxygen

Restrictive oxygenation group

ACTIVE COMPARATOR

SpO2 target of 90%.

Drug: Oxygen

Interventions

Oxygen DRUG

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.

Liberal oxygenation group; Restrictive oxygenation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Bispebjerg Hospital: collaborator

Study Sites (2)

Bispebjerg Hospital

Copenhagen, 2200, Denmark

RECRUITING

Amager-Hvidovre Hospital

Copenhagen, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Hypoxia; Pulmonary Edema

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Jens Hove, MD, PhD

  Copenhagen University Hospital Amager-Hvidovre Department of Cardiology

  STUDY CHAIR

• Johannes Grand, MD, PhD

  Copenhagen University Hospital Amager-Hvidovre Department of Cardiology

  PRINCIPAL INVESTIGATOR

• Ida Taraldsen, MD

  Copenhagen University Hospital Amager-Hvidovre Department of Cardiology

  STUDY DIRECTOR

Central Study Contacts

Johannes Grand, MD, Phd

CONTACT

+4535453545; johannes.grand@regionh.dk

Ida Taraldsen, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 allocation

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: February 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)