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

This study has been completed.
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Arild Hetland, University of Oslo
ClinicalTrials.gov Identifier:
NCT00563693
First received: November 23, 2007
Last updated: December 2, 2015
Last verified: December 2015
  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:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Ejection fraction (measured with echocardiography) and inflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 23, 2007
Last Updated: December 2, 2015
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:
Heart Failure
Cheyne-Stokes Respiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2016