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

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ClinicalTrials.gov Identifier: NCT02518828
Recruitment Status : Recruiting
First Posted : August 10, 2015
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: High SpO2 Other: Low SpO2 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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%




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

Secondary Outcome Measures :
  1. Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours [ Time Frame: 72 hours ]
  2. Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours [ Time Frame: 72 hours ]
  3. Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours [ Time Frame: 72 hours ]
  4. Number of worsening heart failure (WHF) events [ Time Frame: 7 days ]
  5. 30-day clinical events [ Time Frame: 30 days ]
    All cause mortality, HF readmission, days alive and out of hospital

  6. 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 ]
  7. Hochberg endpoint (combination of NT-proBNP and PGA) [ Time Frame: 72 hours ]
  8. Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours) [ Time Frame: 72 hours ]

Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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

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

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02518828     History of Changes
Other Study ID Numbers: HiLo-HF- 2 Pilot Trial
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: February 6, 2018
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