Mitral RegurgitationNCT00970034
Gene Expression Profiles in Patients With Permanent Atrial Fibrillation (AF) Versus Sinus Rhythm (SR)
An observational study of Mitral Regurgitation and Atrial Fibrillation, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF versus SR at transcriptome and genomic size. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Regurgitation, Atrial Fibrillation, Sinus Rhythm
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2008to Dec 2011
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Degenerative mitral valve regurgitation who require cardiac valve surgery
Who may be able to join
- Patients with permanent atrial fibrillation or sinus rhythm and degenerative mitral valve regurgitation who require cardiac surgery
- Pulmonary hypertension (systolic PA > 45 mmHg)
- Left ventricular ejection fraction > 30%
Who cannot join
- Paroxysmal AF or atrial flutter
- Second or third degree heart block
- Permanent pacemaker
- Wolff-Parkinson-White syndrome
- Brugada syndrome
- Ischemic or rheumatic mitral valve disease
Show all 15Show fewer
- Dilated cardiomyopathy
- LVEF < 30%
- Infective endocarditis, myocarditis
- Trauma
- Active HBV, HCV, HIV infection
- Chronic renal failure
- Autoimmune diseases
- Vasculitis
- Known genetic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Medical Faculty, Department of Cardiovascular Surgery,
Ankara, 06340
GUNSELI CUBUKCUOGLU, +905336424994, gunselicubukcu@gmail.com
SERKAN DURDU, +905336373535, serkandurdu@gmail.com
About this study
Official title: Comparative Gene Expression Profiles in Patients With Permanent Atrial Fibrillation and Normal Sinus Rhythm
The aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF versus SR at transcriptome and genomic size.
Read the detailed description
Mitral valve regurgitation (MR) is the second most common valvular heart disease encountered in adults. Furthermore, atrial fibrillation (AF) is the most common cardiac arrhythmia seen in clinical practice. Overall, 70% of the patients with severe MR are associated with AF independent from etiopathogenesis of MR. AF is clinically divided into three subgroups; 1) paroxysmal AF, occurs as episodes and ends spontaneously, 2) persistent AF, episodes terminate only with medical or electrical cardioversion, and 3) permanent AF, current medical treatments and electrical cardioversion does not restore a normal sinus rhythm. Despite intensive electrophysiological studies, the molecular mechanisms and pathways of AF are still not fully elucidated.
Apoptosis which has distinctive morphological and biochemical characteristics is genetically regulated, active programmed cell death process. It is known that cardiac morphogenesis restore from apoptosis. In addition, apoptosis has an important role in several cardiovascular system pathologies. It has been shown that atrial apoptosis causes numerous arrhythmias including AF. Likewise, in the pilot study which has been performed by our study group, AF is associated with apoptosis by immunohistochemical and DNA fragmentation analysis methods.
The aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF by using electron microscopy and immunohistochemistry. Moreover, we will investigate the transcriptional profile of AF associated genes by oligonucleotide microarray method. The gene expression profiles of patients with AF and degenerative MR will be compared with the atrial tissue samples from the patients with degenerative MR who preserve normal sinus rhythm which will serve as controls. In summary the apoptotic pathways would be analyzed at transcriptomic and genomic level. Besides, the pathways that may interfere AF pathophysiology would also be evaluated. The expression profiles of the genes primarily verified by quantitative real time RT-PCR will be further confirmed by translation of end-result proteins determined with Western blot technique. Thus, brand-new clues about physiology of fibrillating atrial cells would be achieved.
Keywords: Atrial fibrillation, apoptosis, oligonucleotide microarray
- Conditions
- Mitral Regurgitation, Atrial Fibrillation, Sinus Rhythm
- Keywords
- Atrial fibrillation, apoptosis, oligonucleotide microarray
- Medical subject headings
- Mitral Valve Insufficiency, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AF | Patients with degenerative mitral valve regurgitation and permanent atrial fibrillation who require mitral valve repair or replacement. | |
| SR | Patients with degenerative mitral valve regurgitation and maintaining sinus rhythm who require mitral valve repair or replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression profiles of genes related to apoptosis
Measured: 6 months
Secondary outcomes (1)
Expression profiles of pro-apoptotic and anti-apoptotic proteins
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startDec 2008
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Investigators
- RUCHAN A AKAR, Assoc. Prof., Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970034
- Sponsor's protocol ID
- 108S375
- Status last verified
- Sep 2009
- First submitted
- 1 Sep 2009
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cubukcuoglu Deniz G, Durdu S, Dogan Y, Erdemli E, Ozdag H, Akar AR. Molecular Signatures of Human Chronic Atrial Fibrillation in Primary Mitral Regurgitation. Cardiovasc Ther. 2021 Oct 15;2021:5516185. doi: 10.1155/2021/5516185. eCollection 2021.
PubMed 34737791
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Gene Expression Profiles in Patients With Permanent Atrial Fibrillation and Normal Sinus Rhythm
- ClinicalTrials.gov ID
- NCT00970034
- Acronym / sponsor ID
- 108S375
- Conditions
- Mitral Regurgitation, Atrial Fibrillation, Sinus Rhythm
- Keywords
- Atrial fibrillation, apoptosis, oligonucleotide microarray
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Dec 2008
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Sep 2009 (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 aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF versus SR at transcriptome and genomic size.
Detailed description
Mitral valve regurgitation (MR) is the second most common valvular heart disease encountered in adults. Furthermore, atrial fibrillation (AF) is the most common cardiac arrhythmia seen in clinical practice. Overall, 70% of the patients with severe MR are associated with AF independent from etiopathogenesis of MR. AF is clinically divided into three subgroups; 1) paroxysmal AF, occurs as episodes and ends spontaneously, 2) persistent AF, episodes terminate only with medical or electrical cardioversion, and 3) permanent AF, current medical treatments and electrical cardioversion does not restore a normal sinus rhythm. Despite intensive electrophysiological studies, the molecular mechanisms and pathways of AF are still not fully elucidated.
Apoptosis which has distinctive morphological and biochemical characteristics is genetically regulated, active programmed cell death process. It is known that cardiac morphogenesis restore from apoptosis. In addition, apoptosis has an important role in several cardiovascular system pathologies. It has been shown that atrial apoptosis causes numerous arrhythmias including AF. Likewise, in the pilot study which has been performed by our study group, AF is associated with apoptosis by immunohistochemical and DNA fragmentation analysis methods.
The aim of this project is to determine the morphological criteria of apoptosis in atrial tissues of patients with AF by using electron microscopy and immunohistochemistry. Moreover, we will investigate the transcriptional profile of AF associated genes by oligonucleotide microarray method. The gene expression profiles of patients with AF and degenerative MR will be compared with the atrial tissue samples from the patients with degenerative MR who preserve normal sinus rhythm which will serve as controls. In summary the apoptotic pathways would be analyzed at transcriptomic and genomic level. Besides, the pathways that may interfere AF pathophysiology would also be evaluated. The expression profiles of the genes primarily verified by quantitative real time RT-PCR will be further confirmed by translation of end-result proteins determined with Western blot technique. Thus, brand-new clues about physiology of fibrillating atrial cells would be achieved.
Keywords: Atrial fibrillation, apoptosis, oligonucleotide microarray
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF | – | –Patients with degenerative mitral valve regurgitation and permanent atrial fibrillation who require mitral valve repair or replacement. |
| SR | – | –Patients with degenerative mitral valve regurgitation and maintaining sinus rhythm who require mitral valve repair or replacement. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Degenerative mitral valve regurgitation who require cardiac valve surgery
Key inclusion criteria (3 listed)
- Patients with permanent atrial fibrillation or sinus rhythm and degenerative mitral valve regurgitation who require cardiac surgery
- Pulmonary hypertension (systolic PA > 45 mmHg)
- Left ventricular ejection fraction > 30%
Key exclusion criteria (15 listed)
- Paroxysmal AF or atrial flutter
- Second or third degree heart block
- Permanent pacemaker
- Wolff-Parkinson-White syndrome
- Brugada syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expression profiles of genes related to apoptosis
Time frame: 6 months
1 secondary outcome
Expression profiles of pro-apoptotic and anti-apoptotic proteins
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2009.
- Derived from this study: PubMed 34737791Cubukcuoglu Deniz G, Durdu S, Dogan Y, Erdemli E, Ozdag H, Akar AR. Molecular Signatures of Human Chronic Atrial Fibrillation in Primary Mitral Regurgitation. Cardiovasc Ther. 2021 Oct 15;2021:5516185. doi: 10.1155/2021/5516185. eCollection 2021.
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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.
RUCHAN A AKAR, Assoc. Prof. principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Atrial Fibrillation, run by Ankara University at 1 site in Turkey (Türkiye).
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 15 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: status not confirmed, as of the sponsor's last update on 3 Sep 2009. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RUCHAN AKAR, Assoc. Prof. (+905336460684, akarruchan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression profiles of genes related to apoptosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970034, which also lists 1 linked publication.
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 3 Sep 2009; AzTrials last refreshed its copy on 7 Nov 2026.