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

Primary Purpose

Heart Failure, Cheyne Stokes Respiration

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
ASV
without Autoset CS2
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cheyne stokes respiration, adaptive servo ventilator

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sykehuset ostfold Fredrikstad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

The patients use ASV

Patients without ASV

Outcomes

Primary Outcome Measures

Ejection fraction (measured with echocardiography) and inflammatory markers

Secondary Outcome Measures

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

Full Information

First Posted
November 23, 2007
Last Updated
December 2, 2015
Sponsor
University of Oslo
Collaborators
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT00563693
Brief Title
Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)
Acronym
3C
Official Title
Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cheyne Stokes Respiration
Keywords
heart failure, cheyne stokes respiration, adaptive servo ventilator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
The patients use ASV
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients without ASV
Intervention Type
Device
Intervention Name(s)
ASV
Other Intervention Name(s)
AutoSet CS2
Intervention Description
Adaptive servo ventilator
Intervention Type
Other
Intervention Name(s)
without Autoset CS2
Intervention Description
without Autoset CS2
Primary Outcome Measure Information:
Title
Ejection fraction (measured with echocardiography) and inflammatory markers
Time Frame
3 months
Secondary Outcome Measure Information:
Title
6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arild Hetland, cardiologist
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset ostfold Fredrikstad
City
Fredrikstad
Country
Norway

12. IPD Sharing Statement

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

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