Pulmonary Hypertension Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | October 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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. — View 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. — View 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. — View 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. doi: 02.2009/JCPSP.8185. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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