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

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ClinicalTrials.gov Identifier: NCT00563693
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Arild Hetland, University of Oslo

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Cheyne Stokes Respiration Device: ASV Other: without Autoset CS2 Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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).
Study Start Date : September 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

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

Responsible Party: Arild Hetland, MD, University of Oslo
ClinicalTrials.gov Identifier: NCT00563693     History of Changes
Other Study ID Numbers: 1.2007.980
First Posted: November 26, 2007    Key Record Dates
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