Heart FailureHiLoNCT02518828
High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
A study testing High SpO2 and Low SpO2 in people with Heart Failure, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- High SpO2 and Low SpO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta Hospital / Mazankowski Alberta Heart Institute
Edmonton, Alberta
About this study
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.
Read the detailed description
Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.
- Conditions
- Heart Failure
- Being tested
- High SpO2, Low SpO2
- Keywords
- Acute Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High SpO2Other
SpO2 range ≥96%
Low SpO2Other
SpO2 range 90-92%
| Study group | Role | What they receive |
|---|---|---|
| High SpO2 | Active comparator | In the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96% Receives: Other: High SpO2 |
| Low SpO2 | Active comparator | In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92% Receives: Other: Low SpO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NT-proBNP from baseline to 72 hours
Measured: 72 hours
Secondary outcomes (8)
Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours
Measured: 72 hours
Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours
Measured: 72 hours
Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours
Measured: 72 hours
Number of worsening heart failure (WHF) events
Measured: 7 days
30-day clinical events
All cause mortality, HF readmission, days alive and out of hospital
Measured: 30 days
Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization
Measured: 30 days
Hochberg endpoint (combination of NT-proBNP and PGA)
Measured: 72 hours
Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJan 2017
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Alberta Innovates Health Solutions
- Responsible party
- Sponsor
- Investigators
- Justin Ezekowitz, MBBCH, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518828
- Sponsor's protocol ID
- HiLo-HF- 2 Pilot Trial
- Acronym
- HiLo
- Status last verified
- Nov 2017
- First submitted
- 4 Aug 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT02518828
- Acronym / sponsor ID
- HiLo / HiLo-HF- 2 Pilot Trial
- Conditions
- Heart Failure
- Keywords
- Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Alberta Innovates Health Solutions
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High SpO2 | Active comparator | Other: High SpO2In the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96% |
| Low SpO2 | Active comparator | Other: Low SpO2In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92% |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (6 listed)
- on home oxygen
- known prior hypercapnic failure (PaCO2 >50 mmHg)
- asthma
- primary pulmonary hypertension,
- patients who require urgent positive pressure ventilation or intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High SpO2SpO2 range ≥96% | Other | High SpO2 |
| Low SpO2SpO2 range 90-92% | Other | Low SpO2 |
Primary outcome
Change in NT-proBNP from baseline to 72 hours
Time frame: 72 hours
8 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Ezekowitz, MBBCH principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High SpO2 and Low SpO2 in people with Heart Failure, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NT-proBNP from baseline to 72 hours (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.