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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 29, 2019
    Last Updated
    September 6, 2019
    Sponsor
    Assiut University
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    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

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    Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

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