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

Primary Purpose

Acute Heart Failure, Pulmonary Congestion, Hypoxemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Oxygen
Sponsored by
Copenhagen University Hospital, Hvidovre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring acute heart failure, Pulmonary edema, Oxygen, Pulmonary congestion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: 1. 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

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liberal oxygenation group

Restrictive oxygenation group

Arm Description

SpO2 target of 96%

SpO2 target of 90%.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2022
Last Updated
September 15, 2023
Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05613218
Brief Title
Oxygen Targets in Acute Heart Failure With Pulmonary Congestion
Acronym
REDOX-AHF
Official Title
Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Pulmonary Congestion, Hypoxemia
Keywords
acute heart failure, Pulmonary edema, Oxygen, Pulmonary congestion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
1:1 allocation
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liberal oxygenation group
Arm Type
Active Comparator
Arm Description
SpO2 target of 96%
Arm Title
Restrictive oxygenation group
Arm Type
Active Comparator
Arm Description
SpO2 target of 90%.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary parenchymal fluid content after 24 hours
Description
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)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Death from all causes
Time Frame
30 days
Title
Days alive out-of-hospital
Time Frame
30 days
Title
Time to freedom from oxygen-supplementation
Time Frame
48 hours
Title
4) Change from baseline in log-transformed biomarkers N-Terminal Pro-Brain Natriuretic Peptide to 24 hours from admission.
Time Frame
24 hours
Title
5) Arterial blood gas concentration after 24 hours preceded by 10 minutes without oxygen-supplementation.
Time Frame
24 hours
Title
Tricuspid annular plane systolic excursion
Time Frame
24 hours
Title
Global longitudinal strain of the right ventricle
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 1. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Grand, MD, Phd
Phone
+4535453545
Email
johannes.grand@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ida Taraldsen, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Hove, MD, PhD
Organizational Affiliation
Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johannes Grand, MD, PhD
Organizational Affiliation
Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ida Taraldsen, MD
Organizational Affiliation
Copenhagen University Hospital Amager-Hvidovre Department of Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olav W Nielsen, MD, DMSc
First Name & Middle Initial & Last Name & Degree
Olav W Nielsen, MD DMSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Oxygen Targets in Acute Heart Failure With Pulmonary Congestion

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