Effect of Heart Valve Replacement on Cheyne-Stokes Respiration

NCT ID: NCT01426776

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-07-31

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.

Detailed Description

Sleep apnea, especially central sleep apnea, has a high prevalence in patients with chronic heart failure. Although sleep disordered breathing (SDB) have been described in patients with heart disease, the prevalence is not known because: ①There are various forms of SDBs, including obstructive sleep apnea(OSA), central sleep apnea (CSA), and mixed forms of sleep apnea syndromes that have variable prevalence; ②Patients suffering from rheumatic valve disease usually have varying degrees of heart failure, and this variability affects estimates of prevalence; ③There are no international patient registries and SDB is underdiagnosed in many parts of the world.

The previous studies are most focusing on nonvalvular disease. We ①investigate the prevalence and the risk factors of Cheyne-Stokes respiration in patients with heart valve diseases, ②compare the changes of parameters of Cheyne-Stokes Respiration and heart function (like apnea hypopnea index, pulse oxygen saturation, blood pressure, echocardiogram, electrocardiogram, 6-minute walk test) before heart valve replacement and 3, 6, and 12 months after the surgery.

With nocturnal polysomnography (PSG) examination 30 patients typical CSR are going to be screened out from 300 patients with heart valve disease and waiting for cardiac surgery. The Comparison of 30 patients undergoing heart valve replacement will be performed before and 3, 6, and 12 months following heart valve replacement. We shall analyze the changes of CSR before and after valve replacement as well as the correlation among cardiac function and PSG parameters.

Conditions

Cheyne-Stokes Respiration; Heart Valve Disease; Central Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

heart valve replacement

a normal surgery that rheumatic valvular heart disease patients received.

Group Type: OTHER

heart valve replacement

Intervention Type: PROCEDURE

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

Interventions

heart valve replacement

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

Intervention Type: PROCEDURE

Other Intervention Names

cardiac surgery

Eligibility Criteria

Inclusion Criteria

• heart valve disease with any ejection fraction
• clinical diagnosis of Cheyne-Stokes respiration

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhang Xilong

Department of Respirology, The First Affiliated Hospital of Nanjing Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shijiang Zhang, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Ning Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 19713650 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14760162 (View on PubMed)

Study Documents

Document Type: published article

We found central sleep apnea was eliminated after cardiac valve replacement surgery, however, there was no change in obstructive sleep apnea.

View Document

Other Identifiers

20092801

Identifier Type: OTHER

Identifier Source: secondary_id

30971319

Identifier Type: -

Identifier Source: org_study_id