Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083729
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdel Fattah Mohamed Ahmed, Assiut University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Procedure: Percutaneous Mitral Commissurotomy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
Masking: Single (Participant)
Masking Description: percutaneous mitral commissurotomy
Primary Purpose: Treatment
Official Title: Predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy and Its Impact on Clinical Outcomes
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patients with persistent pulmonary hypertension
Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy
Procedure: Percutaneous Mitral Commissurotomy
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.
Other Name: Percutaneous mitral valvuloplasty

Active Comparator: Patients without persistent pulmonary hypertension
Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy
Procedure: Percutaneous Mitral Commissurotomy
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.
Other Name: Percutaneous mitral valvuloplasty




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083729


Contacts
Layout table for location contacts
Contact: Mohamed abdelfatah Ahmed +2001121560152 drmohamedabdelfatah@yahoo.com
Contact: Amr Elbadry ibrahim +2001060701601 aelbadry@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Principal Investigator: mohamed Abdelghany Koreim Assiut University, 71515 Assiut, Egypt.
Study Director: Hosam Hasan El Araby Assiut University, 71515 Assiut, Egypt.
Principal Investigator: Amr ElBadry Ibrahim Assiut University, 71515 Assiut, Egypt.
Publications:
Layout table for additonal information
Responsible Party: Mohamed Abdel Fattah Mohamed Ahmed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04083729    
Other Study ID Numbers: PH after mitral commissurtomy
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases