Sleep ApneaMitralHDZNCT02296710
Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
A study testing Echocardiographic and sleep apnea test in people with Sleep Apnea, run by Zisis Dimitriadis at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Echocardiographic and sleep apnea test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mitral valve defect
- NYHA II-IV
- no additional cardiac surgical procedure
Who cannot join
- Pregnancy
- lung disease
- regular follow-up in the study Center in the first 6 months after surgery not guaranteed
- congenital heart disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, 32545
About this study
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.
- Conditions
- Sleep Apnea
- Being tested
- Echocardiographic and sleep apnea test
- Keywords
- mitral valve, valve surgery, echocardiography
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic and sleep apnea testProcedure or surgery
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®)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Echocardiographic and sleep apnea test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of left ventricular systolic function
Measured: 1-4 weeks before and 3 months after surgery
Changes of apnea-hypopnea index
Measured: 1-4 weeks before and 3 months after surgery
Changes of global longitudinal strain
Measured: 1-4 weeks before and 3 months after surgery
Changes of right ventricular systolic function
Measured: 1-4 weeks before and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zisis Dimitriadis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zisis Dimitriadis, Heart and Diabetes Center North-Rhine Westfalia
- Investigators
- Zisis Dimitriadis, MD, Principal investigator, Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296710
- Sponsor's protocol ID
- HDZNRW_KA_003_ZD
- Acronym
- MitralHDZ
- Status last verified
- Mar 2017
- First submitted
- 30 Oct 2014
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Parameter and Sleep Apnea Changes After Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT02296710
- Acronym / sponsor ID
- MitralHDZ / HDZNRW_KA_003_ZD
- Conditions
- Sleep Apnea
- Keywords
- mitral valve, valve surgery, echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Zisis DimitriadisUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiographic and sleep apnea test | Experimental | Procedure: Echocardiographic and sleep apnea testEchocardiographic Evaluation of systolic and diastolic function of both ventricles and evaluation of apnea-hypopnea index and type of apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mitral valve defect
- NYHA II-IV
- no additional cardiac surgical procedure
Key exclusion criteria (4 listed)
- Pregnancy
- lung disease
- regular follow-up in the study Center in the first 6 months after surgery not guaranteed
- congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic and sleep apnea testEchocardiographic 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®) | Procedure or surgery | Echocardiographic and sleep apnea test |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zisis Dimitriadis, MD principal investigator
Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiographic and sleep apnea test in people with Sleep Apnea, run by Zisis Dimitriadis at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of left ventricular systolic function (time frame: 1-4 weeks before and 3 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.