Mitral Valve StenosisNCT06054568
Ventricular-arterial Coupling of the Heart Among Patients With Mitral Stenosis Undergoing Percutaneous Trans-luminal Mitral Commissurotomy. Cardiac Magnetic Resonance Study
An observational study of Mitral Valve Stenosis, run by Assiut University.
Trial summary
Although the incidence of rheumatic fever and its complications has declined in developed countries, the disease remains a major health problem in many developing countries. It is estimated that up to 30 million school-age children and young adults worldwide suffer from chronic rheumatic heart disease, and almost a… Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitral Valve Stenosis
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Mar 2026
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will include patients with mitral stenosis undergoing PTMC
Who may be able to join
- Subjects with severe MS eligible for PTMC according to the recent ESC Guidelines for the management of valvular heart disease 2021
Who cannot join
- Patient with contraindication to CMR (e.g. due to pacemakers, implantable cardioverter defibrillators, claustrophobia, .. etc)
- Patients with associated coronary artery disease.
- Patients with other significant valvular heart disease including organic tricuspid valve disease
- Patients with any type of cardiomyopathy
- Patients with renal impairment
Trial locations and contacts
No sites are listed yet.
About this study
Although the incidence of rheumatic fever and its complications has declined in developed countries, the disease remains a major health problem in many developing countries. It is estimated that up to 30 million school-age children and young adults worldwide suffer from chronic rheumatic heart disease, and almost a third of them suffer from mitral valve stenosis (MS).
Various treatments are currently available to patients, including medical, surgical, and percutaneous mitral commissurotomy (PTMC), depending on the severity of symptoms, the type and severity of mitral stenosis, and the morphology of the mitral valve.
Read more
Successfully performed PTMC increases the optimal mitral valve area and is unlikely to result in significant mitral valve regurgitation. PTMC candidates are selected according to the latest European society of cardiology (ESC) guidelines for the treatment of mitral stenosis based on echocardiographic examination of the mitral valve and its dimensions. The Wilkins score, determined using ultrasound, is an important tool for patient selection.
CMR provides tomographic assessment of the heart with high spatial resolution and enables accurate assessment of ventricular volume, identification of segmental kinetic abnormalities, and detection of tissue changes such as fibrosis, edema, or fatty substitution.
Patients with severe mitral stenosis who underwent percutaneous mitral commissurotomy (PTMC) showed significant changes in right ventricular (RV) function. One study assessed the pre and post changes in RV function after PTMC and found significant improvements in RV parameters such as RV systolic pressure, RV outlet FS, RV TEi index, RV wall thickness, and pulmonary artery systolic pressure.
Successful balloon mitral valvuloplasty (BMV) in patients with rheumatic mitral stenosis (MS) is associated with improvement in left ventricular (LV) function and remodeling. A study using cardiac magnetic resonance imaging (CMR) found that BMV led to an increase in LV peak systolic global longitudinal strain (GLS) and global circumferential strain (GCS) at 6 months, with further improvement at 1 year.
Ventriculo-arterial coupling (VAC) plays an important role in the physiology of cardiac and aortic mechanics as well as in the pathophysiology of heart disease. VAC assessment has independent diagnostic and prognostic value and can be used to improve risk stratification and monitor therapeutic interventions. Traditionally, VAC is assessed by noninvasive measurement of the end-systolic elasticity ratio of arteries (Ea) and ventricles (Ees). Therefore, measuring any component of this ratio or new, more sensitive myocardial markers (e.g.B. global longitudinal strain) and arterial function (e.g. pulse wave velocity) can better characterize the VAC. In valvular heart disease, systemic arterial compliance and valve-arterial impedance have established diagnostic and prognostic value and can monitor the effects of valve replacement on vascular and cardiac function. Treatment to improve VAC by improving one of its components may delay the onset of heart failure and potentially improve the prognosis of heart failure.
According to Ozdogru I et al, A study of patients with severe mitral stenosis undergoing percutaneous balloon valvuloplasty and healthy subjects, demonstrated that mitral stenosis induced an increase in arterial stiffness that was improved after percutaneous balloon valvuloplasty.
Diastolic dysfunction has emerged as an important predictor of adverse outcomes in multiple forms of congenital heart disease.
A recently derived CMR prognostic tool, the left atrioventricular coupling index (LACI), has been evaluated as part of the Multi-Ethnic Study of Atherosclerosis (MESA). LACI is defined as the ratio between LA end-diastolic volume and LV end diastolic volume. It was created to determine whether the close physiological relationship between the LA and LV could serve as a primary prevention tool in the early detection of cardiovascular disease. LACI has been shown to serve as a strong predictor for the incidence of heart failure, atrial fibrillation, cardiovascular disease, and coronary heart disease death in healthy adult populations. A novel right atrioventricular coupling index can potentially help with risk stratification, novel parameter, termed the Right Atrioventricular Coupling Index (RACI), and was defined as the ratio of RA end-diastolic volume to right ventricle (RV) end-diastolic volume.
According to our knowledge there was no specific study was done using cardiac magnetic resonance imaging (CMR) for assessment of Ventricular-arterial coupling pre and post PTMC
- Conditions
- Mitral Valve Stenosis
- Keywords
- Mitral stenosis, cardiac magnetic resonance
- Medical subject headings
- Mitral Valve Stenosis
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 |
|---|---|---|
| Patient with Mitral stenosis undergoing Percutaneous Mitral trans-luminal commissurotomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of atrio-ventricular coupling and ventricular arterial coupling assessed via cardiac magnetic resonance pre and post percutaneous trans-luminal mitral commissurotomy at the pre-specified time points
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve StenosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Zakher Bakhiet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054568
- Sponsor's protocol ID
- Cardiac magnetic resonance
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: because it not decided till now
Publications
Ikonomidis I, Aboyans V, Blacher J, Brodmann M, Brutsaert DL, Chirinos JA, De Carlo M, Delgado V, Lancellotti P, Lekakis J, Mohty D, Nihoyannopoulos P, Parissis J, Rizzoni D, Ruschitzka F, Seferovic P, Stabile E, Tousoulis D, Vinereanu D, Vlachopoulos C, Vlastos D, Xaplanteris P, Zimlichman R, Metra M. The role of ventricular-arterial coupling in cardiac disease and heart failure: assessment, clinical implications and therapeutic interventions. A consensus document of the European Society of Cardiology Working Group on Aorta & Peripheral Vascular Diseases, European Association of Cardiovascular Imaging, and Heart Failure Association. Eur J Heart Fail. 2019 Apr;21(4):402-424. doi: 10.1002/ejhf.1436. Epub 2019 Mar 12.
PubMed 30859669Samaan AA, Said K, Aroussy WE, Hassan M, Romeih S, El Sawy A, Fawzy ME, Yacoub M. Left Ventricular Remodeling Following Balloon Mitral Valvuloplasty in Rheumatic Mitral Stenosis: Magnetic Resonance Imaging Study. Front Cardiovasc Med. 2021 Jun 4;8:674435. doi: 10.3389/fcvm.2021.674435. eCollection 2021.
PubMed 34150869Muhammad, Abdul, Wahab., Syed, Aziz-Ur, Rahman., Umer, Shafiq. (2022). Effect of percutaneous transvenous mitral commisurotomy (ptmc) on right ventricular function. Pakistan Heart Journal, 55(Supplement1):S13-S13. doi: 10.47144/phj.v55isupplement1.2429
Alec Vahanian, Friedhelm Beyersdorf, Fabien Praz, Milan Milojevic, Stephan Baldus, Johann Bauersachs, Davide Capodanno, Lenard Conradi, Michele De Bonis, Ruggero De Paulis, Victoria Delgado, Nick Freemantle, Martine Gilard, Kristina H Haugaa, Anders Jeppsson, Peter Jüni, Luc Pierard, Bernard D Prendergast, J Rafael Sádaba, Christophe Tribouilloy, Wojtek Wojakowski, ESC/EACTS Scientific Document Group , ESC National Cardiac Societies , 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), European Heart Journal, Volume 43, Issue 7, 14 February 2022, Pages 561-632, https://doi.org/10.1093/eurheartj/ehab395
Stefanadis C, Stratos C, Pitsavos C, Kallikazaros I, Triposkiadis F, Trikas A, Vlachopoulos C, Gavaliatsis I, Toutouzas P. Retrograde nontransseptal balloon mitral valvuloplasty. Immediate results and long-term follow-up. Circulation. 1992 May;85(5):1760-7. doi: 10.1161/01.cir.85.5.1760.
PubMed 1572032Seckeler MD, Hoke TR. The worldwide epidemiology of acute rheumatic fever and rheumatic heart disease. Clin Epidemiol. 2011 Feb 22;3:67-84. doi: 10.2147/CLEP.S12977.
PubMed 21386976
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular-arterial Coupling of the Heart Among Patients With Mitral Stenosis Undergoing Percutaneous Trans-luminal Mitral Commissurotomy. Cardiac Magnetic Resonance Study
- ClinicalTrials.gov ID
- NCT06054568
- Acronym / sponsor ID
- Cardiac magnetic resonance
- Conditions
- Mitral Valve Stenosis
- Keywords
- Mitral stenosis, cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Sep 2023 (actual)
- 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.
Although the incidence of rheumatic fever and its complications has declined in developed countries, the disease remains a major health problem in many developing countries. It is estimated that up to 30 million school-age children and young adults worldwide suffer from chronic rheumatic heart disease, and almost a third of them suffer from mitral valve stenosis (MS).
Various treatments are currently available to patients, including medical, surgical, and percutaneous mitral commissurotomy (PTMC), depending on the severity of symptoms, the type and severity of mitral stenosis, and the morphology of the mitral valve.
Successfully performed PTMC increases the optimal mitral valve area and is unlikely to result in significant mitral valve regurgitation. PTMC candidates are selected according to the latest European society of cardiology (ESC) guidelines for the treatment of mitral stenosis based on echocardiographic examination of the mitral valve and its dimensions. The Wilkins score, determined using ultrasound, is an important tool for patient selection.
CMR provides tomographic assessment of the heart with high spatial resolution and enables accurate assessment of ventricular volume, identification of segmental kinetic abnormalities, and detection of tissue changes such as fibrosis, edema, or fatty substitution.
Patients with severe mitral stenosis who underwent percutaneous mitral commissurotomy (PTMC) showed significant changes in right ventricular (RV) function. One study assessed the pre and post changes in RV function after PTMC and found significant improvements in RV parameters such as RV systolic pressure, RV outlet FS, RV TEi index, RV wall thickness, and pulmonary artery systolic pressure.
Successful balloon mitral valvuloplasty (BMV) in patients with rheumatic mitral stenosis (MS) is associated with improvement in left ventricular (LV) function and remodeling. A study using cardiac magnetic resonance imaging (CMR) found that BMV led to an increase in LV peak systolic global longitudinal strain (GLS) and global circumferential strain (GCS) at 6 months, with further improvement at 1 year.
Ventriculo-arterial coupling (VAC) plays an important role in the physiology of cardiac and aortic mechanics as well as in the pathophysiology of heart disease. VAC assessment has independent diagnostic and prognostic value and can be used to improve risk stratification and monitor therapeutic interventions. Traditionally, VAC is assessed by noninvasive measurement of the end-systolic elasticity ratio of arteries (Ea) and ventricles (Ees). Therefore, measuring any component of this ratio or new, more sensitive myocardial markers (e.g.B. global longitudinal strain) and arterial function (e.g. pulse wave velocity) can better characterize the VAC. In valvular heart disease, systemic arterial compliance and valve-arterial impedance have established diagnostic and prognostic value and can monitor the effects of valve replacement on vascular and cardiac function. Treatment to improve VAC by improving one of its components may delay the onset of heart failure and potentially improve the prognosis of heart failure.
According to Ozdogru I et al, A study of patients with severe mitral stenosis undergoing percutaneous balloon valvuloplasty and healthy subjects, demonstrated that mitral stenosis induced an increase in arterial stiffness that was improved after percutaneous balloon valvuloplasty.
Diastolic dysfunction has emerged as an important predictor of adverse outcomes in multiple forms of congenital heart disease.
A recently derived CMR prognostic tool, the left atrioventricular coupling index (LACI), has been evaluated as part of the Multi-Ethnic Study of Atherosclerosis (MESA). LACI is defined as the ratio between LA end-diastolic volume and LV end diastolic volume. It was created to determine whether the close physiological relationship between the LA and LV could serve as a primary prevention tool in the early detection of cardiovascular disease. LACI has been shown to serve as a strong predictor for the incidence of heart failure, atrial fibrillation, cardiovascular disease, and coronary heart disease death in healthy adult populations. A novel right atrioventricular coupling index can potentially help with risk stratification, novel parameter, termed the Right Atrioventricular Coupling Index (RACI), and was defined as the ratio of RA end-diastolic volume to right ventricle (RV) end-diastolic volume.
According to our knowledge there was no specific study was done using cardiac magnetic resonance imaging (CMR) for assessment of Ventricular-arterial coupling pre and post PTMC
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Mitral stenosis undergoing Percutaneous Mitral trans-luminal commissurotomy | – | – |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include patients with mitral stenosis undergoing PTMC
Key inclusion criteria (1 listed)
- Subjects with severe MS eligible for PTMC according to the recent ESC Guidelines for the management of valvular heart disease 2021
Key exclusion criteria (5 listed)
- Patient with contraindication to CMR (e.g. due to pacemakers, implantable cardioverter defibrillators, claustrophobia, .. etc)
- Patients with associated coronary artery disease.
- Patients with other significant valvular heart disease including organic tricuspid valve disease
- Patients with any type of cardiomyopathy
- Patients with renal impairment
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
Assessment of atrio-ventricular coupling and ventricular arterial coupling assessed via cardiac magnetic resonance pre and post percutaneous trans-luminal mitral commissurotomy at the pre-specified time points
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 30859669Ikonomidis I, Aboyans V, Blacher J, Brodmann M, Brutsaert DL, Chirinos JA, De Carlo M, Delgado V, Lancellotti P, Lekakis J, Mohty D, Nihoyannopoulos P, Parissis J, Rizzoni D, Ruschitzka F, Seferovic P, Stabile E, Tousoulis D, Vinereanu D, Vlachopoulos C, Vlastos D, Xaplanteris P, Zimlichman R, Metra M. The role of ventricular-arterial coupling in cardiac disease and heart failure: assessment, clinical implications and therapeutic interventions. A consensus document of the European Society of Cardiology Working Group on Aorta & Peripheral Vascular Diseases, European Association of Cardiovascular Imaging, and Heart Failure Association. Eur J Heart Fail. 2019 Apr;21(4):402-424. doi: 10.1002/ejhf.1436. Epub 2019 Mar 12.
- Background: PubMed 34150869Samaan AA, Said K, Aroussy WE, Hassan M, Romeih S, El Sawy A, Fawzy ME, Yacoub M. Left Ventricular Remodeling Following Balloon Mitral Valvuloplasty in Rheumatic Mitral Stenosis: Magnetic Resonance Imaging Study. Front Cardiovasc Med. 2021 Jun 4;8:674435. doi: 10.3389/fcvm.2021.674435. eCollection 2021.
- BackgroundMuhammad, Abdul, Wahab., Syed, Aziz-Ur, Rahman., Umer, Shafiq. (2022). Effect of percutaneous transvenous mitral commisurotomy (ptmc) on right ventricular function. Pakistan Heart Journal, 55(Supplement1):S13-S13. doi: 10.47144/phj.v55isupplement1.2429
- BackgroundAlec Vahanian, Friedhelm Beyersdorf, Fabien Praz, Milan Milojevic, Stephan Baldus, Johann Bauersachs, Davide Capodanno, Lenard Conradi, Michele De Bonis, Ruggero De Paulis, Victoria Delgado, Nick Freemantle, Martine Gilard, Kristina H Haugaa, Anders Jeppsson, Peter Jüni, Luc Pierard, Bernard D Prendergast, J Rafael Sádaba, Christophe Tribouilloy, Wojtek Wojakowski, ESC/EACTS Scientific Document Group , ESC National Cardiac Societies , 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), European Heart Journal, Volume 43, Issue 7, 14 February 2022, Pages 561-632, https://doi.org/10.1093/eurheartj/ehab395
- Background: PubMed 1572032Stefanadis C, Stratos C, Pitsavos C, Kallikazaros I, Triposkiadis F, Trikas A, Vlachopoulos C, Gavaliatsis I, Toutouzas P. Retrograde nontransseptal balloon mitral valvuloplasty. Immediate results and long-term follow-up. Circulation. 1992 May;85(5):1760-7. doi: 10.1161/01.cir.85.5.1760.
- Background: PubMed 21386976Seckeler MD, Hoke TR. The worldwide epidemiology of acute rheumatic fever and rheumatic heart disease. Clin Epidemiol. 2011 Feb 22;3:67-84. doi: 10.2147/CLEP.S12977.
- Individual participant dataSharing planned: Undecided. because it not decided till now
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Stenosis, run by Assiut University.
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 1 inclusion and 5 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mary Zakher Bakhiet, assistant lecturer (01226714725 ext. +2, mirofelo.711@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of atrio-ventricular coupling and ventricular arterial coupling assessed via cardiac magnetic resonance pre and post percutaneous trans-luminal mitral commissurotomy at the pre-specified time points (time frame: 1 year). 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 NCT06054568, which also lists 6 linked publications.
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 22 Nov 2023.