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

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: High SpO2
* Other: Low SpO2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High SpO2<br>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<br>* SpO2 range ≥96%<br>|
| Active Comparator: Low SpO2<br>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<br>* SpO2 range 90-92%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NT-proBNP from baseline to 72 hours |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Heart Failure