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

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Echocardiographic and sleep apnea test
Sponsored by
Zisis Dimitriadis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea focused on measuring mitral valve, valve surgery, echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart and Diabetes Center North Rhine-Westphalia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echocardiographic and sleep apnea test

Arm Description

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

Outcomes

Primary Outcome Measures

Changes of left ventricular systolic function
Changes of apnea-hypopnea index
Changes of global longitudinal strain
Changes of right ventricular systolic function

Secondary Outcome Measures

Full Information

First Posted
October 30, 2014
Last Updated
March 22, 2017
Sponsor
Zisis Dimitriadis
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1. Study Identification

Unique Protocol Identification Number
NCT02296710
Brief Title
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
Acronym
MitralHDZ
Official Title
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zisis Dimitriadis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
mitral valve, valve surgery, echocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echocardiographic and sleep apnea test
Arm Type
Experimental
Arm Description
Echocardiographic Evaluation of systolic and diastolic function of both ventricles and evaluation of apnea-hypopnea index and type of apnea
Intervention Type
Procedure
Intervention Name(s)
Echocardiographic and sleep apnea test
Intervention Description
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®)
Primary Outcome Measure Information:
Title
Changes of left ventricular systolic function
Time Frame
1-4 weeks before and 3 months after surgery
Title
Changes of apnea-hypopnea index
Time Frame
1-4 weeks before and 3 months after surgery
Title
Changes of global longitudinal strain
Time Frame
1-4 weeks before and 3 months after surgery
Title
Changes of right ventricular systolic function
Time Frame
1-4 weeks before and 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zisis Dimitriadis, MD
Organizational Affiliation
Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart and Diabetes Center North Rhine-Westphalia
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

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Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

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