NCT02296710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

October 30, 2014

Last Update Submit

March 22, 2017

Conditions

Sleep Apnea

Keywords

mitral valvevalve surgeryechocardiography

Outcome Measures

Primary Outcomes (4)

  • Changes of left ventricular systolic function

    1-4 weeks before and 3 months after surgery

  • Changes of apnea-hypopnea index

    1-4 weeks before and 3 months after surgery

  • Changes of global longitudinal strain

    1-4 weeks before and 3 months after surgery

  • Changes of right ventricular systolic function

    1-4 weeks before and 3 months after surgery

Study Arms (1)

Echocardiographic and sleep apnea test

EXPERIMENTAL

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

Echocardiographic and sleep apnea testPROCEDURE

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®)

Echocardiographic and sleep apnea test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Zisis Dimitriadis, MD

    Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident - Cardiologist

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 20, 2014

Study Start

August 1, 2014

Primary Completion

May 1, 2015

Study Completion

March 1, 2017

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

DE(1)