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Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
nocturnal oxygen treatment from oxygen concentrators
Sponsored by
Umeå University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept of respiratory medicine

Outcomes

Primary Outcome Measures

Exercise capacity
Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Brain natriuretic peptide (BNP)

Secondary Outcome Measures

Echocardiography
Radionuclide determination of ejection fraction
Mortality and hospitalization for cardiovascular causes (combined and individually)
Hospitality anxiety and depression scale
Epworth sleepiness scale
Karolinska sleepiness scale
Routine lab (haemoglobins, thyroid status, creatinin)
Urinary catecholamines
Urinary cortisol
Polysomnography
Arrhythmias from 24 hour Holter-ECG registration
Heart rate variability

Full Information

First Posted
June 16, 2006
Last Updated
July 1, 2008
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT00338078
Brief Title
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration
Official Title
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Umeå University

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
nocturnal oxygen treatment from oxygen concentrators
Primary Outcome Measure Information:
Title
Exercise capacity
Title
Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Title
Brain natriuretic peptide (BNP)
Secondary Outcome Measure Information:
Title
Echocardiography
Title
Radionuclide determination of ejection fraction
Title
Mortality and hospitalization for cardiovascular causes (combined and individually)
Title
Hospitality anxiety and depression scale
Title
Epworth sleepiness scale
Title
Karolinska sleepiness scale
Title
Routine lab (haemoglobins, thyroid status, creatinin)
Title
Urinary catecholamines
Title
Urinary cortisol
Title
Polysomnography
Title
Arrhythmias from 24 hour Holter-ECG registration
Title
Heart rate variability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl A Franklin, MD, PhD
Organizational Affiliation
Dept Respiratory Medicine, University Hospital, Umeå
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of respiratory medicine
City
Umeå
ZIP/Postal Code
SE 901 85
Country
Sweden

12. IPD Sharing Statement

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Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

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