Overview

This trial is active, not recruiting.

Condition sleep apnea
Treatment echocardiographic and sleep apnea test
Sponsor Zisis Dimitriadis
Start date August 2014
End date May 2015
Trial size 132 participants
Trial identifier NCT02296710, HDZNRW_KA_003_ZD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Echocardiographic Evaluation of systolic and diastolic function of both ventricles and evaluation of apnea-hypopnea index and type of apnea
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®)

Primary Outcomes

Measure
Changes of left ventricular systolic function
time frame: 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
Changes of global longitudinal strain
time frame: 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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Heart and Diabetes Center North-Rhine Westfalia.