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

Heart Failure Clinical Trial

— 3C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563693
• Other study ID #: 1.2007.980
• Status: Completed
• Phase: N/A
• First received: November 23, 2007
• Last updated: December 2, 2015
• Start date: September 2007
• Est. completion date: January 2011

Study information

• Verified date: December 2015
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cheyne Stokes Respiration
• Cheyne-Stokes Respiration
• Heart Failure

Intervention

Device:
• ASV
Adaptive servo ventilator

Other:
• without Autoset CS2
without Autoset CS2

Locations

Country	Name	City	State
Norway	Sykehuset ostfold Fredrikstad	Fredrikstad

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	ResMed

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction (measured with echocardiography) and inflammatory markers		3 months	No
Secondary	6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias		3 months	No