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CompletedNCT02296710MitralHDZUpdated Mar 23, 2017

Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery

An interventional study of Echocardiographic and sleep apnea test in Sleep Apnea, sponsored by Zisis Dimitriadis. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-23.

Sponsored by Zisis Dimitriadis · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Sleep Apnea

Keywords

  • mitral valve
  • valve surgery
  • echocardiography
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In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 132 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

This is the only study on the registry with Zisis Dimitriadis as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mitral valve defect
  • NYHA II-IV
  • no additional cardiac surgical procedure

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • lung disease
  • regular follow-up in the study Center in the first 6 months after surgery not guaranteed
  • congenital heart disease
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
132 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureEchocardiographic 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®)

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What researchers measure

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

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02296710
Lead sponsor
Zisis Dimitriadis
Responsible party
Zisis Dimitriadis (Resident - Cardiologist, Heart and Diabetes Center North-Rhine Westfalia) — Sponsor-investigator
First posted
Nov 20, 2014
Start date
Aug 2014
Primary completion
May 2015
Completion
Mar 1, 2017
Last update
Mar 23, 2017

Study contacts

Zisis Dimitriadis, MD
principal investigator · Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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