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

This study is currently recruiting participants.
Verified November 2017 by University of Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT02518828
First Posted: August 10, 2015
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Heart and Stroke Foundation of Canada
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
University of Alberta
  Purpose
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.

Condition Intervention
Heart Failure Other: High SpO2 Other: Low SpO2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Change in NT-proBNP from baseline to 72 hours [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours [ Time Frame: 72 hours ]
  • Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours [ Time Frame: 72 hours ]
  • Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours [ Time Frame: 72 hours ]
  • Number of worsening heart failure (WHF) events [ Time Frame: 7 days ]
  • 30-day clinical events [ Time Frame: 30 days ]
    All cause mortality, HF readmission, days alive and out of hospital

  • 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 ]
  • Hochberg endpoint (combination of NT-proBNP and PGA) [ Time Frame: 72 hours ]
  • Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours) [ Time Frame: 72 hours ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 50
Actual Study Start Date: January 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518828


Contacts
Contact: Nariman Sepehrvand, MD hilo@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital / Mazankowski Alberta Heart Institute Recruiting
Edmonton, Alberta, Canada
Contact: Justin Ezekowitz, MD       hilo@ualberta.ca   
Contact: Nariman Sepehrvand, MD       hilo@ualberta.ca   
Principal Investigator: Justin Ezekowitz, MBBCh         
Sponsors and Collaborators
University of Alberta
Heart and Stroke Foundation of Canada
Alberta Innovates Health Solutions
Investigators
Principal Investigator: Justin Ezekowitz, MBBCH University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02518828     History of Changes
Other Study ID Numbers: HiLo-HF- 2 Pilot Trial
First Submitted: August 4, 2015
First Posted: August 10, 2015
Last Update Posted: November 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by University of Alberta:
Acute Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases