Pulmonary HypertensionNCT04083729
Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
A study testing Percutaneous Mitral Commissurotomy in people with Pulmonary Hypertension, run by Assiut University.
Trial summary
To identify clinical, echocardiographic, and hemodynamic parameters which can predict persistent PH after PMC, and also to determine the impact of persistent PH on the clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Percutaneous Mitral Commissurotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe mitral stenosis (mitral valve area ≤1.5cm).
- Significant dyspnea.
- Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography
Who cannot join
- Significant mitral regurgitation (≥ grade II/IV). Bilateral commissural calcification.
- Presence of other lesions which need open heart surgery.
- Wilkins' score > 12.
- Persistent LA thrombus despite adequate anticoagulation.
- End stage renal or liver disease.
- Patients with severe COPD and other chest problems that might be complicated by pulmonary hypertension per se.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy and Its Impact on Clinical Outcomes
To identify clinical, echocardiographic, and hemodynamic parameters which can predict persistent PH after PMC, and also to determine the impact of persistent PH on the clinical outcomes.
Read the detailed description
Pure mitral Stenosis develops in approximately 40% of all patients with rheumatic heart disease, and is frequently complicated by Pulmonary hypertension (PH). Pulmonary hypertension influences symptomatology and long-term prognosis. Percutaneous Mitral Commissurotomy (PMC), was first described in 1984, has good results and is performed by antegrade access to the mitral valve through trans-septal puncture by one of various techniques (e.g. Inuoe, and multitrack system). Pulmonary artery pressures (PAP) decrease following PMC. The improvement in pulmonary hypertension after PMC is explained by the improvement in the mitral valve area and subsequent decompression of left atrium (LA) and pulmonary venous beds. Even though there have been studies showing excellent results following PMC in all grades of PH, nonregression of PH following PMC is not uncommon. The component of PAP contributed by the passive transmission of the elevated LA pressure regresses immediately after a successful PMC proportional to the reduction in transmitral gradient. The PH contributed by pulmonary arteriolar constriction slowly comes down over weeks or a few months, But a "fixed" component due to pulmonary vascular disease usually persists.
- Conditions
- Pulmonary Hypertension
- Being tested
- Percutaneous Mitral Commissurotomy
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Mitral CommissurotomyProcedure or surgery
Also called Percutaneous mitral valvuloplasty
Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area > 1.5 square cm with less than moderate to severe mitral regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| Patients with persistent pulmonary hypertension | Active comparator | Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy Receives: Procedure: Percutaneous Mitral Commissurotomy |
| Patients without persistent pulmonary hypertension | Active comparator | Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy Receives: Procedure: Percutaneous Mitral Commissurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiovascular event
Composite of cardiovascular mortality, cerebral infarction, systemic embolic events ,RV failure ,MV re stenosis that occurred during follow-up, and PMC-related complications; procedural mortality and urgent MV surgery. parameters changes from base line study and after follow up as MVA in cm 2,PASP in mmHg,LAP in mmHg,LVEP in mmHg,PVR in wood unit
Measured: Participants will be followed for a minimum follow-up of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Fattah Mohamed Ahmed, Assiut University
- Investigators
- mohamed Abdelghany Koreim, Principal investigator, Assiut University, 71515 Assiut, Egypt.Hosam Hasan El Araby, Study director, Assiut University, 71515 Assiut, Egypt.Amr ElBadry Ibrahim, Principal investigator, Assiut University, 71515 Assiut, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083729
- Sponsor's protocol ID
- PH after mitral commissurtomy
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hart SA, Krasuski RA, Wang A, Kisslo K, Harrison JK, Bashore TM. Pulmonary hypertension and elevated transpulmonary gradient in patients with mitral stenosis. J Heart Valve Dis. 2010 Nov;19(6):708-15.
PubMed 21214093Noor A, Saghir T, Zaman KS. Determinants of decrease in pulmonary hypertension following percutaneous transvenous mitral commissurotomy. J Coll Physicians Surg Pak. 2009 Feb;19(2):81-5.
PubMed 19208309Bahl VK, Chandra S, Talwar KK, Kaul U, Sharma S, Wasir HS. Balloon mitral valvotomy in patients with systemic and suprasystemic pulmonary artery pressures. Cathet Cardiovasc Diagn. 1995 Nov;36(3):211-5. doi: 10.1002/ccd.1810360304.
PubMed 8542626Fawzy ME, Osman A, Nambiar V, Nowayhed O, El DA, Badr A, Canver CC. Immediate and long-term results of mitral balloon valvuloplasty in patients with severe pulmonary hypertension. J Heart Valve Dis. 2008 Sep;17(5):485-91.
PubMed 18980082
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy and Its Impact on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04083729
- Acronym / sponsor ID
- PH after mitral commissurtomy
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Sep 2019 (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 identify clinical, echocardiographic, and hemodynamic parameters which can predict persistent PH after PMC, and also to determine the impact of persistent PH on the clinical outcomes.
Detailed description
Pure mitral Stenosis develops in approximately 40% of all patients with rheumatic heart disease, and is frequently complicated by Pulmonary hypertension (PH). Pulmonary hypertension influences symptomatology and long-term prognosis. Percutaneous Mitral Commissurotomy (PMC), was first described in 1984, has good results and is performed by antegrade access to the mitral valve through trans-septal puncture by one of various techniques (e.g. Inuoe, and multitrack system). Pulmonary artery pressures (PAP) decrease following PMC. The improvement in pulmonary hypertension after PMC is explained by the improvement in the mitral valve area and subsequent decompression of left atrium (LA) and pulmonary venous beds. Even though there have been studies showing excellent results following PMC in all grades of PH, nonregression of PH following PMC is not uncommon. The component of PAP contributed by the passive transmission of the elevated LA pressure regresses immediately after a successful PMC proportional to the reduction in transmitral gradient. The PH contributed by pulmonary arteriolar constriction slowly comes down over weeks or a few months, But a "fixed" component due to pulmonary vascular disease usually persists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
| Arm | Type | Receives |
|---|---|---|
| Patients with persistent pulmonary hypertension | Active comparator | Procedure: Percutaneous Mitral CommissurotomyPatients with persistent pulmonary hypertension after balloon mitral comisseruotomy |
| Patients without persistent pulmonary hypertension | Active comparator | Procedure: Percutaneous Mitral CommissurotomyPatients without persistent pulmonary hypertension after balloon mitral comisseruotomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe mitral stenosis (mitral valve area ≤1.5cm).
- Significant dyspnea.
- Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography
Key exclusion criteria (6 listed)
- Significant mitral regurgitation (≥ grade II/IV). Bilateral commissural calcification.
- Presence of other lesions which need open heart surgery.
- Wilkins' score > 12.
- Persistent LA thrombus despite adequate anticoagulation.
- End stage renal or liver 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 |
|---|---|---|
| Percutaneous Mitral CommissurotomyAlso: Percutaneous mitral valvuloplastyPercutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area > 1.5 square cm with less than moderate to severe mitral regurgitation. | Procedure or surgery | Patients with persistent pulmonary hypertension, Patients without persistent pulmonary hypertension |
Primary outcome
Composite of cardiovascular event
Time frame: Participants will be followed for a minimum follow-up of one month
Composite of cardiovascular mortality, cerebral infarction, systemic embolic events ,RV failure ,MV re stenosis that occurred during follow-up, and PMC-related complications; procedural mortality and urgent MV surgery. parameters changes from base line study and after follow up as MVA in cm 2,PASP in mmHg,LAP in mmHg,LVEP in mmHg,PVR in wood unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Background: PubMed 21214093Hart SA, Krasuski RA, Wang A, Kisslo K, Harrison JK, Bashore TM. Pulmonary hypertension and elevated transpulmonary gradient in patients with mitral stenosis. J Heart Valve Dis. 2010 Nov;19(6):708-15.
- Background: PubMed 19208309Noor A, Saghir T, Zaman KS. Determinants of decrease in pulmonary hypertension following percutaneous transvenous mitral commissurotomy. J Coll Physicians Surg Pak. 2009 Feb;19(2):81-5.
- Background: PubMed 8542626Bahl VK, Chandra S, Talwar KK, Kaul U, Sharma S, Wasir HS. Balloon mitral valvotomy in patients with systemic and suprasystemic pulmonary artery pressures. Cathet Cardiovasc Diagn. 1995 Nov;36(3):211-5. doi: 10.1002/ccd.1810360304.
- Background: PubMed 18980082Fawzy ME, Osman A, Nambiar V, Nowayhed O, El DA, Badr A, Canver CC. Immediate and long-term results of mitral balloon valvuloplasty in patients with severe pulmonary hypertension. J Heart Valve Dis. 2008 Sep;17(5):485-91.
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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.
mohamed Abdelghany Koreim principal investigator
Assiut University, 71515 Assiut, Egypt.
Hosam Hasan El Araby study director
Assiut University, 71515 Assiut, Egypt.
Amr ElBadry Ibrahim principal investigator
Assiut University, 71515 Assiut, Egypt.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Mitral Commissurotomy in people with Pulmonary Hypertension, 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 3 inclusion and 6 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 10 Sep 2019. 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 Mohamed abdelfatah Ahmed (+2001121560152, drmohamedabdelfatah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular event (time frame: Participants will be followed for a minimum follow-up of one month). 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 NCT04083729, which also lists 4 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 10 Sep 2019.