Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
Primary Purpose
Pulmonary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous Mitral Commissurotomy
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria:
- Severe mitral stenosis (mitral valve area ≤1.5cm).
- Significant dyspnea.
- Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with persistent pulmonary hypertension
Patients without persistent pulmonary hypertension
Arm Description
Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy
Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04083729
Brief Title
Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
Official Title
Predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy and Its Impact on Clinical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
Masking
Participant
Masking Description
percutaneous mitral commissurotomy
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with persistent pulmonary hypertension
Arm Type
Active Comparator
Arm Description
Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy
Arm Title
Patients without persistent pulmonary hypertension
Arm Type
Active Comparator
Arm Description
Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Mitral Commissurotomy
Other Intervention Name(s)
Percutaneous mitral valvuloplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of cardiovascular event
Description
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
Time Frame
Participants will be followed for a minimum follow-up of one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe mitral stenosis (mitral valve area ≤1.5cm).
Significant dyspnea.
Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed abdelfatah Ahmed
Phone
+2001121560152
Email
drmohamedabdelfatah@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Elbadry ibrahim
Phone
+2001060701601
Email
aelbadry@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed Abdelghany Koreim
Organizational Affiliation
Assiut University, 71515 Assiut, Egypt.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hosam Hasan El Araby
Organizational Affiliation
Assiut University, 71515 Assiut, Egypt.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amr ElBadry Ibrahim
Organizational Affiliation
Assiut University, 71515 Assiut, Egypt.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21214093
Citation
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.
Results Reference
background
PubMed Identifier
19208309
Citation
Noor 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.
Results Reference
background
PubMed Identifier
8542626
Citation
Bahl 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.
Results Reference
background
PubMed Identifier
18980082
Citation
Fawzy 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.
Results Reference
background
Learn more about this trial
Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
We'll reach out to this number within 24 hrs