Clinical trial NCT04083729: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Composite of cardiovascular event
timeFrame: Participants will be followed for a minimum follow-up of one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University, 71515 Assiut, Egypt.
name: mohamed Abdelghany Koreim
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University, 71515 Assiut, Egypt.
name: Hosam Hasan El Araby
role: STUDY_DIRECTOR
affiliation: Assiut University, 71515 Assiut, Egypt.
name: Amr ElBadry Ibrahim
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.