Rheumatic Heart Disease Clinical Trial
Official title:
Randomised Controlled Trial Into the Role of Ramipril in Fibrosis Reduction in Rheumatic Heart Disease: The RamiRHeD Trial Protocol
Objective propose: to investigate the effect of Ramipril in suppressing ST2 (suppression of tumorigenicity 2) in the cardiac mitral valve in patients with Rheumatic Heart Disease. We hypothesized that we hypothesized that ramipril will improve rheumatic mitral valve fibrosis through the downregulation of ST2.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | August 8, 2024 |
Est. primary completion date | August 8, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients with mitral valve stenosis or a combination - aged more than 18 years - undergo cardiac valve replacement operation with or without a tricuspid valve repair, - patients with systolic blood pressure (SBP) = 100 mmHg and diastolic blood pressure (DBP) = 60 mmHg - passed in medication phase without side effect minimum 4 weeks until operation schedule Exclusion Criteria: 1. Patients with congenital heart disease 2. patients with non-mitral valve surgery 3. patients with coronary artery bypass surgery 4. patients who refuse to join this study. 5. adults aged over 65 years or older 6. pregnant women 7. patients with autoimmune disease. 8. Patients with persistent hypotension (systolic blood pressure (BP) < 100 mm Hg) 9. severe aortic stenosis (aortic valve orifice < 0.75 cm2 ) 10. chronic renal dysfunction with serum creatinine > 2.5 mg/ dL, 11. known ACEI intolerance. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Ade Meidian Ambari | Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Ambari AM, Setianto B, Santoso A, Radi B, Dwiputra B, Susilowati E, Tulrahmi F, Doevendans PA, Cramer MJ. Angiotensin Converting Enzyme Inhibitors (ACEIs) Decrease the Progression of Cardiac Fibrosis in Rheumatic Heart Disease Through the Inhibition of IL-33/sST2. Front Cardiovasc Med. 2020 Jul 28;7:115. doi: 10.3389/fcvm.2020.00115. eCollection 2020. Review. — View Citation
Ciccone MM, Cortese F, Gesualdo M, Riccardi R, Di Nunzio D, Moncelli M, Iacoviello M, Scicchitano P. A novel cardiac bio-marker: ST2: a review. Molecules. 2013 Dec 11;18(12):15314-28. doi: 10.3390/molecules181215314. Review. — View Citation
Shi Q, Abusarah J, Baroudi G, Fernandes JC, Fahmi H, Benderdour M. Ramipril attenuates lipid peroxidation and cardiac fibrosis in an experimental model of rheumatoid arthritis. Arthritis Res Ther. 2012 Oct 18;14(5):R223. doi: 10.1186/ar4062. — View Citation
Wei Q, Liu H, Liu M, Yang C, Yang J, Liu Z, Yang P. Ramipril attenuates left ventricular remodeling by regulating the expression of activin A-follistatin in a rat model of heart failure. Sci Rep. 2016 Sep 19;6:33677. doi: 10.1038/srep33677. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ST2 expression in mitral valve tissue and papillary muscle | expression of ST2 in mitral valve tissue, using immunohistochemistry method | a year | |
Secondary | ST2 Plasma concentration | plasma level of ST2 measured by ELISA | a year | |
Secondary | NT-proBNP concentration (pg/ml) | concentration of NT-proBNP, plasma markers for cardiac dysfunction. | a year | |
Secondary | NYHA class | related symptoms will be graded in class I to IV according to NYHA. | a year | |
Secondary | cardiovascular mortality | Study participants will be followed up until 1 year after the surgery for any mortality that is caused by progression of the cardiac disease | 1 year | |
Secondary | All-cause mortality | Study participants will be followed up until 1 year after the surgery for mortality of any cause. | 1 year | |
Secondary | End diastolic dimension | The diameter across a ventricle at the end of diastole, if not else specified then usually referring to the transverse (left-to-right) internal (luminal) distance, excluding thickness of walls, although it can also be measured as the external distance. | 1 year | |
Secondary | End systolic dimension | The diameter across a ventricle at the end of systole, if not else specified then usually referring to the transverse (left-to-right) internal (luminal) distance, excluding thickness of walls, although it can also be measured as the external distance. | 1 year | |
Secondary | Mitral valve area | mitral valve area is the area of mitral valve, measured by the Gorlin formula MVA (cm2) = (CO ÷ DFP) ÷ (38.0 x MPG) where MVA is the mitral valve area, CO is cardiac output, DFP is the diastolic flow period, 38.0 is the constant and MPG is pressure gradient. | 1 year | |
Secondary | Mitral valve gradient | mitralvalve graient is a echocardiographic parameters of the pressure gradient in the mitral valve | 1 year | |
Secondary | Tricuspid maximal velocity (Vmax) | Tricuspid maximal velocity (Vmax) is the echocardiographic parameters of the maximal velocity in tricuspid valve annulus | 1 year | |
Secondary | Tricuspid regurgitation severity | TRicuspid regurgitation severity is classified ad mild, moderate, and severe, according to European Association of Echocardiography measurement year 2010 for Tricuspid Valve regusrgitation severity. | 1 year | |
Secondary | Ejection fraction | echocardiographic parameter to asses ventricular function | 1 year | |
Secondary | TAPSE (tricuspid annular plane systolic excursion) | echocardiography parameter to asses right ventricular function | 1 year |
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