We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00563693
First Posted: November 26, 2007
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ResMed
Information provided by (Responsible Party):
Arild Hetland, University of Oslo
  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: None (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:


Further study details as provided by Arild Hetland, 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 ]

Enrollment: 40
Study Start Date: September 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563693


Locations
Norway
Sykehuset ostfold Fredrikstad
Fredrikstad, Norway
Sponsors and Collaborators
University of Oslo
ResMed
Investigators
Principal Investigator: Arild Hetland, cardiologist University of Oslo
  More Information

Responsible Party: Arild Hetland, MD, University of Oslo
ClinicalTrials.gov Identifier: NCT00563693     History of Changes
Other Study ID Numbers: 1.2007.980
First Submitted: November 23, 2007
First Posted: November 26, 2007
Last Update Posted: December 3, 2015
Last Verified: December 2015

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

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