Acute Heart FailureNCT03110042
HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
An observational study of Acute Heart Failure, run by University of Alberta at 1 site in Canada.
Trial summary
The HILO-HF Registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with a primary ED diagnosis of AHF Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Heart Failure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Apr 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Patients >40 years of age presenting to the ED with AHF
Who may be able to join
- Patients >40 years of age presenting to the ED with AHF
- With or without tested BNP
- With or without admission to hospital for treatment of HF\
- Patients must be recruited within the first 24 hours of presenting to the ED.
Who cannot join
- Patients on home oxygen
- Patients with known prior hypercapnic failure (PaCO2>50 mmHg)
- Asthma
- Primary pulmonary hypertension
- Patients requiring urgent positive pressure ventilation or intubation or 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
Official title: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
The HILO-HF Registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with a primary ED diagnosis of AHF
- Conditions
- Acute Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | All patients will receive usual standard of care with the heart failure management including the routine supplemental oxygen therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood oxygen saturation levels from baseline to 72 hours
Measured: 72 hours
Secondary outcomes (5)
Dyspnea on visual analogue scale (VAS) to 72 hours
Measured: 72 hours
Change in global symptoms using Patient Global Assessment (PGA) measure to 72 hours
Measured: 72 hours
Change in Peak Expiratory Flow
Measured: 72 hours
Rate of patients with Worsening Heart Failure
Measured: 7 days
30-day composite clinical event (all-cause mortality, HF readmission, days alive and out of hospital)
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startNov 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Ezekowitz, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110042
- Sponsor's protocol ID
- HILO-HF Registry
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2017
- Last updated
- 26 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. 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
- NCT03110042
- Acronym / sponsor ID
- HILO-HF Registry
- Conditions
- Acute Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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 HILO-HF Registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with a primary ED diagnosis of AHF
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | –All patients will receive usual standard of care with the heart failure management including the routine supplemental oxygen therapy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >40 years of age presenting to the ED with AHF
Key inclusion criteria (4 listed)
- Patients >40 years of age presenting to the ED with AHF
- With or without tested BNP
- With or without admission to hospital for treatment of HF\
- Patients must be recruited within the first 24 hours of presenting to the ED.
Key exclusion criteria (5 listed)
- Patients on home oxygen
- Patients with known prior hypercapnic failure (PaCO2>50 mmHg)
- Asthma
- Primary pulmonary hypertension
- Patients requiring urgent positive pressure ventilation or intubation or on >10 L/min oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in blood oxygen saturation levels from baseline to 72 hours
Time frame: 72 hours
5 secondary outcomes
Dyspnea on visual analogue scale (VAS) to 72 hours
Time frame: 72 hours
Change in global symptoms using Patient Global Assessment (PGA) measure to 72 hours
Time frame: 72 hours
Change in Peak Expiratory Flow
Time frame: 72 hours
Rate of patients with Worsening Heart Failure
Time frame: 7 days
30-day composite clinical event (all-cause mortality, HF readmission, days alive and out of hospital)
Time frame: 30days
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 26 Apr 2019.
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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, MD 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?
An observational study of Acute 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 4 inclusion and 5 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 26 Apr 2019. 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 blood oxygen saturation levels 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 26 Apr 2019.