HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

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

The HILO-HF Registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with a primary ED diagnosis of AHF

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital / Mazankowski Alberta Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients >40 years of age presenting to the ED with AHF

Description

Inclusion Criteria:

• Patients >40 years of age presenting to the ED with AHF
• With or without tested BNP
• With or without admission to hospital for treatment of HF\
• Patients must be recruited within the first 24 hours of presenting to the ED.

Exclusion Criteria:

• Patients on home oxygen
• Patients with known prior hypercapnic failure (PaCO2>50 mmHg)
• Asthma
• Primary pulmonary hypertension
• Patients requiring urgent positive pressure ventilation or intubation or on >10 L/min oxygen

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observational Cohort; All patients will receive usual standard of care with the heart failure management including the routine supplemental oxygen therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in blood oxygen saturation levels from baseline to 72 hours	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Dyspnea on visual analogue scale (VAS) to 72 hours	72 hours
Change in global symptoms using Patient Global Assessment (PGA) measure to 72 hours	72 hours
Change in Peak Expiratory Flow	72 hours
Rate of patients with Worsening Heart Failure	7 days
30-day composite clinical event (all-cause mortality, HF readmission, days alive and out of hospital)	30days

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Justin Ezekowitz, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: April 1, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HILO-HF Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No