Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (... | NCT00563693

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

NCT00563693

Sponsor

University of Oslo

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Heart Failure
Cheyne Stokes Respiration

Interventions

ASV
without Autoset CS2

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Nov 23, 2007

First Submission Date that Met QC Criteria

Nov 23, 2007

First Posted Date

Nov 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Name	Class
ResMed	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	The patients use ASV	Device: ASV Other: without Autoset CS2
B	Active Comparator	Patients without ASV	Other: without Autoset CS2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASV	Device	Adaptive servo ventilator	A	AutoSet CS2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arild Hetland, cardiologist	University of Oslo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset ostfold Fredrikstad		Fredrikstad			Norway

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D002639	Cheyne-Stokes Respiration

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided