High Flow Oxygen Therapy in Patients with Sleep Apnea and Heart Failure

Phase 1

• Conditions: Cheyne-Stokes Respiration in chronic heart failure; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-001357-40-DE
• Lead Sponsor: Klinik für Kardiologie, Herz- und Diabeteszentrum NRW

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-28
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18-90 years
• New York Heart Association (NYHA) class II to IV
• Left ventricular ejection fraction = 45%
• Predominantly central sleep apnea (AHI =15 events per hour, with >80% central events [apnea or hypopnea] and a central AHI of =10 events per hour)
• Hypoxemic burden = 25%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

• daytime hypercapnia (pCO2 > 45 mmHg)
• ongoing ventilation therapy
• cardiothoracic surgery within the last 3 months
• myocardial infarction within the last 6 months
• unstable angina
• acute myocarditis
• stroke within the last 3 months
• epilepsy, known cerebral damage, dementia
• untreated restless-legs-syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified