Mitral StenosisNCT06067815
Assessment of Right Ventricular Function in Patients With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
An observational study of Mitral Stenosis, run by Assiut University.
Trial summary
To detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Mitral Stenosis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Nov 2024
- 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
- Child, Adult, Older adult
Study population: Patients with severe mitral stenosis,not impairment left ventricular function
Who may be able to join
- Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).
- Patient with normal left ventricular EF.
- patient with sinus rhythm or AF
- patient with any degree of pulmonary HTN
Who cannot join
- Patient with another valve lesion or more than mild mitral regurgitation.
- Patient with impaired cardiac function.
- patient with coronary arteries disease
- Mitral stenosis of other etiology than rheumatic origin.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Right Ventricular Function in Patient With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
To detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function
Read the detailed description
In patients with mitral valve stenosis, right ventricular failure may develop either by the rheumatic process directly or through hemodynamic alterations resulting from pulmonary vascular changes.
Right ventricular (RV) function plays an important role in development of clinical symptoms and prognosis in patients with mitral stenosis (MS).This is primarily affected by hemodynamic effects on RV due to pulmonary hypertension(PH).
In the last two decades, Percutaneous Transluminal Mitral Commissurotomy (PTMC) has become the treatment of choice for patients with symptomatic rheumatic MS . Using this method,Mitral Valve Area (MVA) can be increased, which can improve the hemodynamic and clinical features of patients with MS .
RV functional assessment is difficult and not done routinely because of its complex anatomy and high load dependence.
Different modalitis are used to assess RV function as Tissue Doppler and two-dimensional (2D) speckle tracking method has been used to quantify strain for assessment Myocardial strain is a measure of tissue deformation, which is expressed as a percentage change.
- Conditions
- Mitral Stenosis
- Medical subject headings
- Mitral Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare RV function before and after PTMC
echocardiogram
Measured: 1 year
Secondary outcomes (2)
To measure the right side pressure changes invasively before and after PTMC
Right sided heart catheterization
Measured: 1 year
To compare the effect of PTMC on RV function in patient with AF and sinus rythm
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (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 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmin Zakaria Basheir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067815
- Sponsor's protocol ID
- Mitral stenosis PTMC
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kumar V, Jose VJ, Pati PK, Jose J. Assessment of right ventricular strain and strain rate in patients with severe mitral stenosis before and after balloon mitral valvuloplasty. Indian Heart J. 2014 Mar-Apr;66(2):176-82. doi: 10.1016/j.ihj.2014.02.012. Epub 2014 Mar 1.
PubMed 24814111
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular Function in Patient With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
- ClinicalTrials.gov ID
- NCT06067815
- Acronym / sponsor ID
- Mitral stenosis PTMC
- Conditions
- Mitral Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 5 Oct 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.
To detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function
Detailed description
In patients with mitral valve stenosis, right ventricular failure may develop either by the rheumatic process directly or through hemodynamic alterations resulting from pulmonary vascular changes.
Right ventricular (RV) function plays an important role in development of clinical symptoms and prognosis in patients with mitral stenosis (MS).This is primarily affected by hemodynamic effects on RV due to pulmonary hypertension(PH).
In the last two decades, Percutaneous Transluminal Mitral Commissurotomy (PTMC) has become the treatment of choice for patients with symptomatic rheumatic MS . Using this method,Mitral Valve Area (MVA) can be increased, which can improve the hemodynamic and clinical features of patients with MS .
RV functional assessment is difficult and not done routinely because of its complex anatomy and high load dependence.
Different modalitis are used to assess RV function as Tissue Doppler and two-dimensional (2D) speckle tracking method has been used to quantify strain for assessment Myocardial strain is a measure of tissue deformation, which is expressed as a percentage change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe mitral stenosis,not impairment left ventricular function
Key inclusion criteria (4 listed)
- Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).
Key exclusion criteria (4 listed)
- Patient with another valve lesion or more than mild mitral regurgitation.
- Patient with impaired cardiac function.
- patient with coronary arteries disease
- Mitral stenosis of other etiology than rheumatic origin.
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
To compare RV function before and after PTMC
Time frame: 1 year
echocardiogram
2 secondary outcomes
To measure the right side pressure changes invasively before and after PTMC
Time frame: 1 year
To compare the effect of PTMC on RV function in patient with AF and sinus rythm
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 24814111Kumar V, Jose VJ, Pati PK, Jose J. Assessment of right ventricular strain and strain rate in patients with severe mitral stenosis before and after balloon mitral valvuloplasty. Indian Heart J. 2014 Mar-Apr;66(2):176-82. doi: 10.1016/j.ihj.2014.02.012. Epub 2014 Mar 1.
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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 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 4 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: status not confirmed, as of the sponsor's last update on 5 Oct 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 Yassmin Zakaria Basheir (01115429471, Yass.min97@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare RV function before and after PTMC (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 NCT06067815, 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 5 Oct 2023.