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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2006-001446-14 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Torasemide prolonged released |
|
| 2 | Active Comparator | Furosemide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Torasemide Prolonged Release | Drug | Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure) | 8 months | |
| Cardiovascular events | 8 months | |
| NT-proBNP (Brain Natriuretic Peptide) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Coca, MD, PhD | Hospital Clinic of Barcelona | Study Chair |
| Manuel Anguita, MD, PhD | Hospital Reina Sofia - Córdoba | Study Chair |
| Eduardo De Teresa, MD, PhD | Hospital Clinico - Málaga | Study Chair |
| Alfonso Castro Beiras, MD, PhD | Hospital Juan Canalejo - Coruña | Study Chair |
| Javier Díez | Centro Investigación Médica Aplicada (CIMA) - Pamplona (Navarra) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinc Hospital | Barcelona | Barcelona | Spain | |||
| Germans Trias i Pujol Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15313958 | 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. | |
| 16046900 | Background |
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| Furosemide | Drug | Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months |
|
|
| 8 months |
| Hospitalizations, home care due to cardiovascular causes related to heart failure | 8 months |
| Safety and tolerability | 8 months |
| Quality of Life (Minnesota Test) | 8 months |
| Barcelona |
| Barcelona |
| Spain |
| H. del Mar | Barcelona | Barcelona | Spain |
| Valle Hebrón Hospital | Barcelona | Barcelona | Spain |
| Canet de Mar, Primary Care Centre | Canet de Mar | Barcelona | Spain |
| Centelles - Primar Care Centre | Centellas | Barcelona | Spain |
| El Maresme - Primary Care Centre | Mataró | Barcelona | Spain |
| Remei, Primary care centre | Vic | Barcelona | Spain |
| Reina Sofia Hospital | Córdoba | Córdoba | Spain |
| Josep Trueta Hospital | Girona | Girona | Spain |
| San Jorge Hospital | Huesca | Huesca | Spain |
| Complejo Hospitalario Juan Canalejo | A Coruña | La Coruña | Spain |
| Begonte - Primary Care Centre | Begonte | Lugo | Spain |
| Gregorio Marañón Hospital | Madrid | Madrid | Spain |
| Clinico Universitario Virgen de la Victoria | Málaga | Malaga | Spain |
| Virgen de la Arrixaca | Murcia | Murcia | Spain |
| Central Hospital | Oviedo | Principality of Asturias | Spain |
| Clinico Universitario Hospital | Salamanca | Salamanca | Spain |
| Donostia Hospital | Donostia / San Sebastian | San Sebastián | Spain |
| Clinico Universitario de Santiago | Santiago de Compostela | Santiago de Compostela | Spain |
| Alcover - primary care centre | Alcover | Tarragona | Spain |
| General Hospital | Valencia | Valencia | Spain |
| Clinico Universitario | Zaragoza | Zaragoza | Spain |
| 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. |
| 15172408 | 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. |
| 16003166 | 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. |
| 17719472 | 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. |
| 21906812 | Derived | 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. |
| 19673667 | Derived | 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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