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

Heart Failure Clinical Trial

— HiLo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518828
• Other study ID #: HiLo-HF- 2 Pilot Trial
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2018

Study information

• Verified date: November 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• High SpO2
SpO2 range =96%
• Low SpO2
SpO2 range 90-92%

Locations

Country	Name	City	State
Canada	University of Alberta Hospital / Mazankowski Alberta Heart Institute	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions, Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Change in NT-proBNP from baseline to 72 hours		72 hours
Secondary	Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours		72 hours
Secondary	Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours		72 hours
Secondary	Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours		72 hours
Secondary	Number of worsening heart failure (WHF) events		7 days
Secondary	30-day clinical events	All cause mortality, HF readmission, days alive and out of hospital	30 days
Secondary	Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization		30 days
Secondary	Hochberg endpoint (combination of NT-proBNP and PGA)		72 hours
Secondary	Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)		72 hours