Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

Phase 2

Recruiting

• Conditions: Pulmonary Congestion; Acute Heart Failure; Hypoxemia
• Interventions: Drug: Oxygen

• Registration Number: NCT05613218
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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.

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.

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-14
• Status Verified: 2024-02
• Study Start: 2024-02-01
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2025-04-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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:

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal oxygenation group	Oxygen	SpO2 target of 96%
Restrictive oxygenation group	Oxygen	SpO2 target of 90%.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to freedom from oxygen-supplementation	48 hours
All-cause mortality	30 days	Death from all causes
Days alive out-of-hospital	30 days
Tricuspid annular plane systolic excursion	24 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
Global longitudinal strain of the right ventricle	24 hours

Trial Locations

Locations (2)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Amager-Hvidovre Hospital; 🇩🇰 Copenhagen, Denmark