High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
HiLo
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedNovember 6, 2018
November 1, 2017
1.5 years
August 4, 2015
November 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in NT-proBNP from baseline to 72 hours
72 hours
Secondary Outcomes (8)
Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours
72 hours
Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours
72 hours
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours
72 hours
Number of worsening heart failure (WHF) events
7 days
30-day clinical events
30 days
- +3 more secondary outcomes
Other Outcomes (1)
Safety Outcome - Need for mechanical ventilation (invasive and non-invasive
7 days
Study Arms (2)
High SpO2
ACTIVE COMPARATORIn the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96%
Low SpO2
ACTIVE COMPARATORIn the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92%
Interventions
Eligibility Criteria
You may qualify if:
- \>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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Heart and Stroke Foundation of Canadacollaborator
- Alberta Innovates Health Solutionscollaborator
Study Sites (1)
University of Alberta Hospital / Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin Ezekowitz, MBBCH
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 10, 2015
Study Start
January 1, 2017
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
November 6, 2018
Record last verified: 2017-11