Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery (MitralHDZ)

March 22, 2017 updated by: Zisis Dimitriadis
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

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

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Heart and Diabetes Center North Rhine-Westphalia

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: 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®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of left ventricular systolic function
Time Frame: 1-4 weeks before and 3 months after surgery
1-4 weeks before and 3 months after surgery
Changes of apnea-hypopnea index
Time Frame: 1-4 weeks before and 3 months after surgery
1-4 weeks before and 3 months after surgery
Changes of global longitudinal strain
Time Frame: 1-4 weeks before and 3 months after surgery
1-4 weeks before and 3 months after surgery
Changes of right ventricular systolic function
Time Frame: 1-4 weeks before and 3 months after surgery
1-4 weeks before and 3 months after surgery

Collaborators and Investigators

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

Sponsor

Zisis Dimitriadis

Investigators

  • Principal Investigator: Zisis Dimitriadis, MD, Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia

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

August 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZNRW_KA_003_ZD

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.

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