Acute Heart Failure Clinical Trial
Official title:
High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
| NCT number | NCT03110042 |
| Other study ID # | HILO-HF Registry |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2016 |
| Est. completion date | April 2019 |
| Verified date | April 2019 |
| Source | University of Alberta |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 2019 |
| Est. primary completion date | April 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Alberta Hospital / Mazankowski Alberta Heart Institute | Edmonton | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alberta |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in blood oxygen saturation levels from baseline to 72 hours | 72 hours | ||
| Secondary | Dyspnea on visual analogue scale (VAS) to 72 hours | 72 hours | ||
| Secondary | Change in global symptoms using Patient Global Assessment (PGA) measure to 72 hours | 72 hours | ||
| Secondary | Change in Peak Expiratory Flow | 72 hours | ||
| Secondary | Rate of patients with Worsening Heart Failure | 7 days | ||
| Secondary | 30-day composite clinical event (all-cause mortality, HF readmission, days alive and out of hospital) | 30days |
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