CClinicalTrials.gg
CompletedNCT005636933CUpdated Dec 3, 2015

Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)

An interventional study of ASV and without Autoset CS2 in Heart Failure and Cheyne Stokes Respiration, sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by University of Oslo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life.

Read the detailed description

Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.

Several patients with chronic heart failure also has Cheyne Stokes respiration pattern. Earlier studies have shown that this respiration pattern improves with Adaptive servo ventilator. We wish to investigate wether this leads to improved cardiac function.

02

Conditions studied

  • Heart Failure
  • Cheyne Stokes Respiration

Keywords

  • heart failure
  • cheyne stokes respiration
  • adaptive servo ventilator
03

In context

Cheyne-Stokes Respiration

23 studies on the registry are indexed under Cheyne-Stokes Respiration; 1 is open to participants now.

This study's enrollment of 40 is below the median of 48 across 20 interventional studies indexed under Cheyne-Stokes Respiration.

Browse Cheyne-Stokes Respiration studies →

Lead sponsor

University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ejection fraction \<40%
  • NYHA class III-IV
  • Optimized therapy with drugs
  • Cheyne stokes respiration pattern > 25% while sleeping
  • Age \< 85 years
  • clinical stability the last month before inclusion.

Exclusion criteria

Exclusion Criteria:

  • CABG less then 6 months ago
  • PCI treatment less then 3 months ago
  • Unstable angina pectoris
  • Acute coronary syndrome less then 3 months ago
  • Stroke less then 6 weeks ago
  • Thoracal myopathy
  • Advanced COPD
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    A

    The patients use ASV

    Device: ASV · Other: without Autoset CS2

  • Active comparator
    B

    Patients without ASV

    Other: without Autoset CS2

Interventions

  • DeviceASV

    Adaptive servo ventilator

    Also known as: AutoSet CS2

  • Otherwithout Autoset CS2

    without Autoset CS2

06

What researchers measure

Primary outcomes

  1. Ejection fraction (measured with echocardiography) and inflammatory markers

    Time frame: 3 months

Secondary outcomes

  1. 6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias

    Time frame: 3 months

07

Study locations

1 site
  • Sykehuset ostfold Fredrikstad
    Fredrikstad, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00563693
Lead sponsor
University of Oslo
Collaborators
ResMed
Responsible party
Arild Hetland (MD, University of Oslo) — Principal investigator
First posted
Nov 26, 2007
Start date
Sep 2007
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Dec 3, 2015

Study contacts

Arild Hetland, cardiologist
principal investigator · University of Oslo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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