Clinical trial NCT01426776: Effect of Heart Valve Replacement on Cheyne-Stokes Respiration
Official title: Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheyne-Stokes Respiration
Heart Valve Disease
Central Sleep Apnea
Keywords: Cheyne-Stokes respiration
Heart valve disease
Central Sleep Apnea
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Changes of CSR index before and 3, 6, 12 months following valve replacement.
timeFrame: 1 year after cardiac surgery of each enrolled patient
Secondary outcomes:
measure: Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement
timeFrame: 1 year after cardiac surgery of each enrolled patient
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shijiang Zhang, MD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ning Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.