Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

Heart Failure Clinical Trial

Official title:

Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338078
• Other study ID #: 241/98, dnr 98-165
• Status: Completed
• Phase: N/A
• First received: June 16, 2006
• Last updated: July 1, 2008
• Start date: March 1999
• Est. completion date: December 2006

Study information

• Verified date: June 2008
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.

Description:

Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• Stable heart failure with left ventricular dysfunction

• Cheyne-Stokes respiration with central AHI>15 and obstructive AHI<5

Exclusion Criteria:

• Heart infarction within 3 months.

• Dementia

• Chronic obstructive pulmonary disease and daytime hypoxemia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cheyne-Stokes Respiration
• Heart Failure

Intervention

Device:
• nocturnal oxygen treatment from oxygen concentrators

Locations

Country	Name	City	State
Sweden	Dept of respiratory medicine	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity
Primary	Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Primary	Brain natriuretic peptide (BNP)
Secondary	Echocardiography
Secondary	Radionuclide determination of ejection fraction
Secondary	Mortality and hospitalization for cardiovascular causes (combined and individually)
Secondary	Hospitality anxiety and depression scale
Secondary	Epworth sleepiness scale
Secondary	Karolinska sleepiness scale
Secondary	Routine lab (haemoglobins, thyroid status, creatinin)
Secondary	Urinary catecholamines
Secondary	Urinary cortisol
Secondary	Polysomnography
Secondary	Arrhythmias from 24 hour Holter-ECG registration
Secondary	Heart rate variability