Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep

Launched by FISHER AND PAYKEL HEALTHCARE · May 29, 2014

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and Women aged ≥ 18 years
• • Heart Failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months
• • Left ventricular systolic dysfunction (LVEF ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). All echocardiography must be within a maximum of 1 year of the screening visit.
• • New York Heart Association Class II or III after optimization of medical therapy
• • Stable Clinical Status on stable optimal medical therapy for ≥ 1 month before entry
• Exclusion Criteria:
• • Unstable angina
• • Myocardial infarction within the last 12 months
• • Cardiac surgery within the previous 6 months
• • Pregnancy
• • Unwilling or unable to provide informed consent
• • Uncontrolled arrhythmias
• • Severe valvular heart disease
• • Current/prior use of mechanical ventilation (including CPAP). At the investigator's discretion.

Trial Officials