Effect of Heart Valve Replacement on Cheyne-Stokes Respiration (CSR)

February 23, 2020 updated by: Zhang Xilong, Nanjing Medical University

Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • the First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: heart valve replacement
a normal surgery that rheumatic valvular heart disease patients received.
Procedure: heart valve replacement
The patients with heart valve disease and CSR will be received heart valve replacement
Other Names:
  • cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of CSR index before and 3, 6, 12 months following valve replacement.
Time Frame: 1 year after cardiac surgery of each enrolled patient
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement
Time Frame: 1 year after cardiac surgery of each enrolled patient
The secondary goal of this study is to determine the association of PSG parameters(index of CSR, apnea hypopnea index, pulse oxygen saturation, electrocardiogram, etc)and cardiac function (LVEF, 6-minute walk test, etc) before and 3, 6, 12 months following the cardiac valve replacement surgery. Qualities of life and sleep will also be masured before and 3, 6, 12 months after surgery. (The quality of life is assessed by reference to "The Medical Outcomes Study 36item Short-Form Health Survey"(SF-36) generic questionnaire, and sleep quality is assessed by Pittsburgh Sleep Quality Index(PSQI).)
1 year after cardiac surgery of each enrolled patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Investigators

  • Study Director: Shijiang Zhang, MD, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Ning Ding, Doctor, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

August 28, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (ESTIMATE)

August 31, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30971319
  • 20092801 (OTHER: Ethic committee)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. published article
    Information identifier: PMID: 24938583
    Information comments: We found central sleep apnea was eliminated after cardiac valve replacement surgery, however, there was no change in obstructive sleep apnea.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cheyne-Stokes Respiration

Clinical Trials on heart valve replacement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe