NCT00563693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

November 23, 2007

Last Update Submit

December 2, 2015

Conditions

Heart FailureCheyne Stokes Respiration

Keywords

heart failurecheyne stokes respirationadaptive servo ventilator

Outcome Measures

Primary Outcomes (1)

  • Ejection fraction (measured with echocardiography) and inflammatory markers

    3 months

Secondary Outcomes (1)

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

    3 months

Study Arms (2)

A

EXPERIMENTAL

The patients use ASV

Device: ASVOther: without Autoset CS2

B

ACTIVE COMPARATOR

Patients without ASV

Other: without Autoset CS2

Interventions

ASVDEVICE

Adaptive servo ventilator

Also known as: AutoSet CS2
A
without Autoset CS2OTHER

without Autoset CS2

AB

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ejection fraction \<40%
  • NYHA class III-IV
  • Optimized therapy with drugs
  • Cheyne stokes respiration pattern \> 25% while sleeping
  • Age \< 85 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset ostfold Fredrikstad

Fredrikstad, Norway

Location

MeSH Terms

Conditions

Heart FailureCheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arild Hetland, cardiologist

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 23, 2007

First Posted

November 26, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

NO(1)