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

December 2, 2015 updated by: Arild Hetland, University of Oslo

Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Fredrikstad, Norway
        • Sykehuset ostfold Fredrikstad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
The patients use ASV
Device: ASV
Adaptive servo ventilator
Other Names:
  • AutoSet CS2
Other: without Autoset CS2
without Autoset CS2
Active Comparator: B
Patients without ASV
Other: without Autoset CS2
without Autoset CS2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ejection fraction (measured with echocardiography) and inflammatory markers
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

ResMed

Investigators

  • Principal Investigator: Arild Hetland, cardiologist, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

November 23, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.2007.980

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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