NCT01212705

Brief Summary

Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive servoventilation on cardiac function, exercise tolerance and quality of life in patients with chronic heart failure.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
Last Updated

October 1, 2010

Status Verified

September 1, 2010

First QC Date

September 30, 2010

Last Update Submit

September 30, 2010

Conditions

Chronic Heart FailureCentral Sleep ApneaCheyne-Stokes Respiration

Study Arms (1)

ASV

EXPERIMENTAL
Device: Adaptive servoventilation

Interventions

Adaptive servoventilationDEVICE

Background expiratory positive airway pressure with some inspiratory pressure support when needed

ASV

Eligibility Criteria

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

You may qualify if:

  • chronic heart failure with ejection fraction ≤45%
  • optimal medical treatment for at least 1 month
  • clinical diagnosis of Cheyne-Stokes respiration

You may not qualify if:

  • unstable heart failure
  • stroke
  • transient ischemic attack in last 6 months
  • pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance
  • severe chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medicine

Warsaw, Szaserow 128, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, CentralCheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Kazimierczak

    Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Kazimierczak

CONTACT

48 22 6818017annakazimierczak@poczta.onet.pl

Krystian Krzyzanowski

CONTACT

48 512 356 207krystian.krzyzanowski@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 1, 2010

Last Updated

October 1, 2010

Record last verified: 2010-09

Locations

PL(1)