Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

NCT ID: NCT02296710

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-03-01

Brief Summary

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The investigators evaluate the changes of echocardiographic and sleep apnea parameters after mitral valve surgery. The patients undergo echocardiographic and sleep apnea control before surgery. After a period of 3-5 months, they undergo a second echocardiographic and sleep apnea control and the results are evaluated.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Echocardiographic and sleep apnea test

Echocardiographic Evaluation of systolic and diastolic function of both ventricles and evaluation of apnea-hypopnea index and type of apnea

Group Type EXPERIMENTAL

Echocardiographic and sleep apnea test

Intervention Type PROCEDURE

Echocardiographic evaluation (Vivid 7, GE) of systolic and diastolic function of both ventricles as well as evaluation of apnea-hypopnea index and type of apnea (ApneaLink®)

Interventions

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Echocardiographic and sleep apnea test

Echocardiographic evaluation (Vivid 7, GE) of systolic and diastolic function of both ventricles as well as evaluation of apnea-hypopnea index and type of apnea (ApneaLink®)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* mitral valve defect
* NYHA II-IV
* no additional cardiac surgical procedure

Exclusion Criteria

* Pregnancy
* lung disease
* regular follow-up in the study Center in the first 6 months after surgery not guaranteed
* congenital heart disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zisis Dimitriadis

OTHER

Sponsor Role lead

Responsible Party

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Zisis Dimitriadis

Resident - Cardiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zisis Dimitriadis, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia

Locations

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Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HDZNRW_KA_003_ZD

Identifier Type: -

Identifier Source: org_study_id

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