Clinical trial NCT05613218: Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Official title: Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Heart Failure
Pulmonary Congestion
Hypoxemia
Keywords: acute heart failure
Pulmonary edema
Oxygen
Pulmonary congestion
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2022-11-14
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 allocation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary parenchymal fluid content after 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days
measure: Days alive out-of-hospital
timeFrame: 30 days
measure: Time to freedom from oxygen-supplementation
timeFrame: 48 hours
measure: 4) Change from baseline in log-transformed biomarkers N-Terminal Pro-Brain Natriuretic Peptide to 24 hours from admission.
timeFrame: 24 hours
measure: 5) Arterial blood gas concentration after 24 hours preceded by 10 minutes without oxygen-supplementation.
timeFrame: 24 hours
measure: Tricuspid annular plane systolic excursion
timeFrame: 24 hours
measure: Global longitudinal strain of the right ventricle
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Amager-Hvidovre Hospital
Study officials:
affiliation: Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
name: Jens Hove, MD, PhD
role: STUDY_CHAIR
affiliation: Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
name: Johannes Grand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
name: Ida Taraldsen, MD
role: STUDY_DIRECTOR
References: