NCT04083729

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

August 29, 2019

Last Update Submit

September 6, 2019

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

    Participants will be followed for a minimum follow-up of one month

Study Arms (2)

Patients with persistent pulmonary hypertension

ACTIVE COMPARATOR

Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy

Procedure: Percutaneous Mitral Commissurotomy

Patients without persistent pulmonary hypertension

ACTIVE COMPARATOR

Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy

Procedure: Percutaneous Mitral Commissurotomy

Interventions

Percutaneous Mitral CommissurotomyPROCEDURE

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.

Also known as: Percutaneous mitral valvuloplasty
Patients with persistent pulmonary hypertensionPatients without persistent pulmonary hypertension

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe mitral stenosis (mitral valve area ≤1.5cm).
  • Significant dyspnea.
  • Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 21214093BACKGROUND

  • 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.

    PMID: 19208309BACKGROUND

  • 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.

    PMID: 8542626BACKGROUND

  • 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.

    PMID: 18980082BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • mohamed Abdelghany Koreim

    Assiut University, 71515 Assiut, Egypt.

    PRINCIPAL INVESTIGATOR

  • Hosam Hasan El Araby

    Assiut University, 71515 Assiut, Egypt.

    STUDY DIRECTOR

  • Amr ElBadry Ibrahim

    Assiut University, 71515 Assiut, Egypt.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed abdelfatah Ahmed

CONTACT

+2001121560152drmohamedabdelfatah@yahoo.com

Amr Elbadry ibrahim

CONTACT

+2001060701601aelbadry@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
percutaneous mitral commissurotomy
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 10, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

September 10, 2019

Record last verified: 2019-09