HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in... | NCT03110042

Studies
HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

NCT03110042

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Apr 26, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Acute Heart Failure

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Apr 2019Actual

Completion Date

Apr 2019Actual

First Submitted Date

Apr 1, 2017

First Submission Date that Met QC Criteria

Apr 5, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2019

Last Update Posted Date

Apr 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational Cohort		All patients will receive usual standard of care with the heart failure management including the routine supplemental oxygen therapy.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in blood oxygen saturation levels from baseline to 72 hours		72 hours

Secondary Outcomes

Measure	Description	Time Frame
Dyspnea on visual analogue scale (VAS) to 72 hours		72 hours
Change in global symptoms using Patient Global Assessment (PGA) measure to 72 hours		72 hours
Change in Peak Expiratory Flow

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients >40 years of age presenting to the ED with AHF

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Justin Ezekowitz, MD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospital / Mazankowski Alberta Heart Institute		Edmonton	Alberta		Canada