Heart Failure
Conditions
Keywords
Acute Heart Failure
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.
Interventions
OTHERHigh SpO2
SpO2 range ≥96%
OTHERLow SpO2
SpO2 range 90-92%
Sponsors
Heart and Stroke Foundation of Canada
Alberta Innovates Health Solutions
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in NT-proBNP from baseline to 72 hours | 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of worsening heart failure (WHF) events | 7 days | — |
| Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours | 72 hours | — |
| Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours | 72 hours | — |
| Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours | 72 hours | — |
| 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 | — |
| 30-day clinical events | 30 days | All cause mortality, HF readmission, days alive and out of hospital |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome - Need for mechanical ventilation (invasive and non-invasive | 7 days | Number of participants with post-enrollment respiratory failure with a need for mechanical ventilation as assessed by CTCAE v4.0 |
Countries
Canada
Outcome results
None listed