Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

September 6, 2019 updated by: Mohamed Abdel Fattah Mohamed Ahmed, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Percutaneous mitral valvuloplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for a minimum follow-up of one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH after mitral commissurtomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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