NCT00338078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Mar 1999

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 2, 2008

Status Verified

June 1, 2008

First QC Date

June 16, 2006

Last Update Submit

July 1, 2008

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

  • Exercise capacity

  • Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)

  • Brain natriuretic peptide (BNP)

Secondary Outcomes (12)

  • Echocardiography

  • Radionuclide determination of ejection fraction

  • Mortality and hospitalization for cardiovascular causes (combined and individually)

  • Hospitality anxiety and depression scale

  • Epworth sleepiness scale

  • +7 more secondary outcomes

Interventions

nocturnal oxygen treatment from oxygen concentratorsDEVICE

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable heart failure with left ventricular dysfunction
  • Cheyne-Stokes respiration with central AHI\>15 and obstructive AHI\<5

You may not qualify if:

  • Heart infarction within 3 months.
  • Dementia
  • Chronic obstructive pulmonary disease and daytime hypoxemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of respiratory medicine

Umeå, SE 901 85, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Karl A Franklin, MD, PhD

    Dept Respiratory Medicine, University Hospital, Umeå

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

March 1, 1999

Study Completion

December 1, 2006

Last Updated

July 2, 2008

Record last verified: 2008-06

Locations

SE(1)