An interventional study of High SpO2 and Low SpO2 in Heart Failure, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-11-06.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96%
Other: High SpO2
In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92%
Other: Low SpO2
SpO2 range ≥96%
SpO2 range 90-92%
Change in NT-proBNP from baseline to 72 hours
Time frame: 72 hours
Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours
Time frame: 72 hours
Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours
Time frame: 72 hours
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours
Time frame: 72 hours
Number of worsening heart failure (WHF) events
Time frame: 7 days
30-day clinical events
All cause mortality, HF readmission, days alive and out of hospital
Time frame: 30 days
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
Hochberg endpoint (combination of NT-proBNP and PGA)
Time frame: 72 hours
Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)
Time frame: 72 hours
Safety Outcome - Need for mechanical ventilation (invasive and non-invasive
Number of participants with post-enrollment respiratory failure with a need for mechanical ventilation as assessed by CTCAE v4.0
Time frame: 7 days
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Alberta