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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University of Oslo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ResMed
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00563693
First received: November 23, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Failure
Cheyne Stokes Respiration
 Device: ASV
Other: without Autoset CS2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Ejection fraction (measured with echocardiography) and inflammatory markers [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias [ Time Frame: 3 months ]

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
Experimental: A
The patients use ASV
 Device: ASV
Adaptive servo ventilator
Other Name: AutoSet CS2
Other: without Autoset CS2
without Autoset CS2
Active Comparator: B
Patients without ASV
 Other: without Autoset CS2
without Autoset CS2

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563693

Contacts
Contact: Arild Hetland, cardiologist +4769860000 arildhet@online.no
Contact: Stian Ross +4769860000 stian.ross@so-hf.no

Locations
Norway
Sykehuset ostfold Fredrikstad Recruiting
Fredrikstad, Norway
Contact: Arild Hetland, cardiologist     +4769860000     arildhet@online.no    
Contact: Stian Ross, dr     +4769860000     stian.ross@so-hf.no    
Principal Investigator: Arild Hetland, cardiologist            
Sponsors and Collaborators
University of Oslo
ResMed
Investigators
Principal Investigator: Arild Hetland, cardiologist University of Oslo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00563693     History of Changes
Other Study ID Numbers: 1.2007.980
Study First Received: November 23, 2007
Last Updated: November 23, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
heart failure
cheyne stokes respiration
adaptive servo ventilator

Additional relevant MeSH terms:
Cheyne-Stokes Respiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013