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

November 5, 2018 updated by: University of Alberta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: High SpO2
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
SpO2 range ≥96%
ACTIVE_COMPARATOR: Low SpO2
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
SpO2 range 90-92%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in NT-proBNP from baseline to 72 hours
Time Frame: 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
Time Frame: 72 hours
72 hours
Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours
Time Frame: 72 hours
72 hours
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours
Time Frame: 72 hours
72 hours
Number of worsening heart failure (WHF) events
Time Frame: 7 days
7 days
30-day clinical events
Time Frame: 30 days
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
Time Frame: 30 days
30 days
Hochberg endpoint (combination of NT-proBNP and PGA)
Time Frame: 72 hours
72 hours
Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)
Time Frame: 72 hours
72 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Outcome - Need for mechanical ventilation (invasive and non-invasive
Time Frame: 7 days
Number of participants with post-enrollment respiratory failure with a need for mechanical ventilation as assessed by CTCAE v4.0
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Alberta Innovates Health Solutions
Heart and Stroke Foundation of Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (ESTIMATE)

August 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiLo-HF- 2 Pilot Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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