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Completed

NCT Number: NCT02518828

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital / Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High SpO2

Other

SpO2 range ≥96%

Low SpO2

Other

SpO2 range 90-92%

Primary outcomes

  1. Change in NT-proBNP from baseline to 72 hours

    Time frame: 72 hours

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Innovates Health Solutions
  • Heart and Stroke Foundation of Canada

Registry information

Acronym: HiLo

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2015
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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