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Completed

NCT Number: NCT02296710

Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiographic and sleep apnea test

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®)

Primary outcomes

  1. Changes of left ventricular systolic function

    Time frame: 1-4 weeks before and 3 months after surgery

  2. Changes of apnea-hypopnea index

    Time frame: 1-4 weeks before and 3 months after surgery

  3. Changes of global longitudinal strain

    Time frame: 1-4 weeks before and 3 months after surgery

  4. Changes of right ventricular systolic function

    Time frame: 1-4 weeks before and 3 months after surgery

Sponsors and collaborators

Lead sponsor

Zisis Dimitriadis

Other

Registry information

Acronym: MitralHDZ

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Nov 20, 2014
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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