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High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure (HiLo)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High SpO2
Low SpO2
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Acute Heart Failure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >40 years of age presenting to the ED with AHF
  • objective finding of HF (BNP >400 pg/ml or Chest X-Ray with pulmonary congestion)
  • plan to admit with primary diagnosis as HF
  • must be able to be randomized within 16 hours of presenting to the ED
  • provided written informed consent

Exclusion Criteria:

  • on home oxygen
  • known prior hypercapnic failure (PaCO2 >50 mmHg)
  • asthma
  • primary pulmonary hypertension,
  • patients who require urgent positive pressure ventilation or intubation
  • patients on >10 L/min oxygen

Sites / Locations

  • University of Alberta Hospital / Mazankowski Alberta Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High SpO2

Low SpO2

Arm Description

In the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96%

In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92%

Outcomes

Primary Outcome Measures

Change in NT-proBNP from baseline to 72 hours

Secondary Outcome Measures

Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours
Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours
Number of worsening heart failure (WHF) events
30-day clinical events
All cause mortality, HF readmission, days alive and out of hospital
Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization
Hochberg endpoint (combination of NT-proBNP and PGA)
Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)

Full Information

First Posted
August 4, 2015
Last Updated
November 5, 2018
Sponsor
University of Alberta
Collaborators
Heart and Stroke Foundation of Canada, Alberta Innovates Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT02518828
Brief Title
High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
Acronym
HiLo
Official Title
High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Heart and Stroke Foundation of Canada, Alberta Innovates Health Solutions

4. Oversight

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

5. Study Description

Brief Summary
The primary objective of this pilot trial is to determine whether inpatients presenting to the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who receive supplemental oxygen adjusted at either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP) at 72 hours.
Detailed Description
Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Acute Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High SpO2
Arm Type
Active Comparator
Arm Description
In the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96%
Arm Title
Low SpO2
Arm Type
Active Comparator
Arm Description
In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92%
Intervention Type
Other
Intervention Name(s)
High SpO2
Intervention Description
SpO2 range ≥96%
Intervention Type
Other
Intervention Name(s)
Low SpO2
Intervention Description
SpO2 range 90-92%
Primary Outcome Measure Information:
Title
Change in NT-proBNP from baseline to 72 hours
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours
Time Frame
72 hours
Title
Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours
Time Frame
72 hours
Title
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours
Time Frame
72 hours
Title
Number of worsening heart failure (WHF) events
Time Frame
7 days
Title
30-day clinical events
Description
All cause mortality, HF readmission, days alive and out of hospital
Time Frame
30 days
Title
Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization
Time Frame
30 days
Title
Hochberg endpoint (combination of NT-proBNP and PGA)
Time Frame
72 hours
Title
Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Safety Outcome - Need for mechanical ventilation (invasive and non-invasive
Description
Number of participants with post-enrollment respiratory failure with a need for mechanical ventilation as assessed by CTCAE v4.0
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >40 years of age presenting to the ED with AHF objective finding of HF (BNP >400 pg/ml or Chest X-Ray with pulmonary congestion) plan to admit with primary diagnosis as HF must be able to be randomized within 16 hours of presenting to the ED provided written informed consent Exclusion Criteria: on home oxygen known prior hypercapnic failure (PaCO2 >50 mmHg) asthma primary pulmonary hypertension, patients who require urgent positive pressure ventilation or intubation patients on >10 L/min oxygen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ezekowitz, MBBCH
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital / Mazankowski Alberta Heart Institute
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

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High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

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