Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.

Summary

Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment of oedema associated to heart failure, kidney or liver disease and either in the treatment of arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been developed a new formulation of Torasemide (Torasemide prolonged release). The aim of this trial is to study the effects of Torasemide prolonged released in comparison with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart failure (Class II-IV of the New York Heart Association Classification.

Timeline

Start

2007-03

Primary completion

2009-06

Completion

2009-06

Publications

• Background Querejeta R, Lopez B, Gonzalez A, Sanchez E, Larman M, Martinez Ubago JL, Diez J. Increased collagen type I synthesis in patients with heart failure of hypertensive origin: relation to myocardial fibrosis. Circulation. 2004 Sep 7;110(10):1263-8. doi: 10.1161/01.CIR.0000140973.60992.9A. Epub 2004 Aug 16.
• Background Gonzalez A, Lopez B, Diez J. New directions in the assessment and treatment of hypertensive heart disease. Curr Opin Nephrol Hypertens. 2005 Sep;14(5):428-34. doi: 10.1097/01.mnh.0000174143.30045.bd.
• Background Lopez B, Querejeta R, Gonzalez A, Sanchez E, Larman M, Diez J. Effects of loop diuretics on myocardial fibrosis and collagen type I turnover in chronic heart failure. J Am Coll Cardiol. 2004 Jun 2;43(11):2028-35. doi: 10.1016/j.jacc.2003.12.052.
• Background Lopez B, Gonzalez A, Querejeta R, Diez J. The use of collagen-derived serum peptides for the clinical assessment of hypertensive heart disease. J Hypertens. 2005 Aug;23(8):1445-51. doi: 10.1097/01.hjh.0000173780.67308.f1.
• Background Lopez B, Gonzalez A, Beaumont J, Querejeta R, Larman M, Diez J. Identification of a potential cardiac antifibrotic mechanism of torasemide in patients with chronic heart failure. J Am Coll Cardiol. 2007 Aug 28;50(9):859-67. doi: 10.1016/j.jacc.2007.04.080. Epub 2007 Aug 13.
• TORAFIC Investigators Group. Effects of prolonged-release torasemide versus furosemide on myocardial fibrosis in hypertensive patients with chronic heart failure: a randomized, blinded-end point, active-controlled study. Clin Ther. 2011 Sep;33(9):1204-1213.e3. doi: 10.1016/j.clinthera.2011.08.006. Epub 2011 Sep 8.
• Diez J, Coca A, de Teresa E, Anguita M, Castro-Beiras A, Conthe P, Cobo E, Fernandez E; TORAFIC Investigators Group. TORAFIC study protocol: torasemide prolonged release versus furosemide in patients with chronic heart failure. Expert Rev Cardiovasc Ther. 2009 Aug;7(8):897-904. doi: 10.1586/erc.09.74.

Drugs

Indications