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NCT02296710 Clinical Trial

Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

Sleep Apnea Clinical Trial

— MitralHDZ  

Official title:
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02296710
Other study ID # HDZNRW_KA_003_ZD
Secondary ID
Status Completed
Phase N/A
First received October 30, 2014
Last updated March 22, 2017
Start date August 2014
Est. completion date March 1, 2017

Study information
Verified date March 2017
Source Heart and Diabetes Center North-Rhine Westfalia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date March 1, 2017
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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®)

Locations
Country Name City State
Germany Heart and Diabetes Center North Rhine-Westphalia Bad Oeynhausen

Sponsors (1)
Lead Sponsor Collaborator
Zisis Dimitriadis

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of left ventricular systolic function 1-4 weeks before and 3 months after surgery
Primary Changes of apnea-hypopnea index 1-4 weeks before and 3 months after surgery
Primary Changes of global longitudinal strain 1-4 weeks before and 3 months after surgery
Primary Changes of right ventricular systolic function 1-4 weeks before and 3 months after surgery
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