NCT01426776

Brief Summary

Sleep disordered breathing, especially central sleep apnea, is common in patients with chronic heart failure. Heart valve replacement could have some effect on central sleep apnea. The aim of the study is to investigate effect of heart valve replacement on Cheyne-Stokes respiration in patients with rheumatic heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

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, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

August 28, 2011

Last Update Submit

February 23, 2020

Conditions

Cheyne-Stokes RespirationHeart Valve DiseaseCentral Sleep Apnea

Keywords

Cheyne-Stokes respirationHeart valve diseaseCentral Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Changes of CSR index before and 3, 6, 12 months following valve replacement.

    The primary goal of this study is to compare the changes of polysomnography(PSG) parameters(index of CSR, apnea hypopnea index, pulse oxygen saturation, etc)before and 3, 6, 12 months following the cardiac valve replacement surgery.

    1 year after cardiac surgery of each enrolled patient

Secondary Outcomes (1)

  • Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement

    1 year after cardiac surgery of each enrolled patient

Study Arms (1)

heart valve replacement

OTHER

a normal surgery that rheumatic valvular heart disease patients received.

Procedure: heart valve replacement

Interventions

heart valve replacementPROCEDURE

The patients with heart valve disease and CSR will be received heart valve replacement

Also known as: cardiac surgery
heart valve replacement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • heart valve disease with any ejection fraction
  • 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)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (2)

  • Abe H, Takahashi M, Yaegashi H, Eda S, Kitahara H, Tsunemoto H, Kamikozawa M, Koyama J, Yamazaki K, Ikeda U. Valve repair improves central sleep apnea in heart failure patients with valvular heart diseases. Circ J. 2009 Nov;73(11):2148-53. doi: 10.1253/circj.cj-09-0307. Epub 2009 Aug 28.

    PMID: 19713650BACKGROUND

  • Rubin AE, Gottlieb SH, Gold AR, Schwartz AR, Smith PL. Elimination of central sleep apnoea by mitral valvuloplasty: the role of feedback delay in periodic breathing. Thorax. 2004 Feb;59(2):174-6. doi: 10.1136/thorax.2003.007799.

    PMID: 14760162RESULT

MeSH Terms

Conditions

Cheyne-Stokes RespirationHeart Valve DiseasesSleep Apnea, Central

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Shijiang Zhang, MD

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

  • Ning Ding, Doctor

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respirology, The First Affiliated Hospital of Nanjing Medical University

Study Record Dates

First Submitted

August 28, 2011

First Posted

August 31, 2011

Study Start

September 1, 2010

Primary Completion

February 1, 2012

Study Completion

July 1, 2012

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

CN(1)