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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
| Alberta Innovates Health Solutions | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High SpO2 | Active Comparator | In 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 Comparator | In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High SpO2 | Other | SpO2 range ≥96% |
| |
| Low SpO2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-proBNP from baseline to 72 hours | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Ezekowitz, MBBCH | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital / Mazankowski Alberta Heart Institute | Edmonton | Alberta | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Other |
SpO2 range 90-92% |
|
| 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 | All cause mortality, HF readmission, days alive and out of hospital | 30 days |
| Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization | 30 days |
| Hochberg endpoint (combination of NT-proBNP and PGA) | 72 hours |
| Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours) | 72 hours |