Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
NCT ID: NCT00409942
Last Updated: 2009-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
142 participants
INTERVENTIONAL
2007-03-31
2009-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Torasemide prolonged released
Torasemide Prolonged Release
Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
2
Furosemide
Furosemide
Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
Interventions
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Torasemide Prolonged Release
Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
Furosemide
Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with chronic heart failure class II-IV (NYHA)due to arterial hypertension
* Patients clinically stable who required diuretic treatment
* Patients with left ventricular hypertrophy diagnosed by echocardiogram
* Patients without ischaemic cardiopathy or non recent disease
* Signed Informed Consent
Exclusion Criteria
* Recent coronary syndrome (less than 3 months)
* Recent myocardial infarction (less than 6 months)
* Unstable angor pectoris
* Severe cardiac arrhythmia
* Pregnancy or breastfeeding
* Aldosterone antagonists (last 6 months)
* Current loop diuretic treatment over study doses (torasemide \> 10mg/day furosemide \> 40 mg/day)
* known hypersensitivity to study drugs
* Liver disease (SGPT or AST \> twice upper normal limt)
* Renal impairment (Serum creatinine \> 2,5mg/dl)
* Insulin-dependent diabetes
* Patient included in another simultaneous study
* Lactose intolerance
* Lithium Concomitant treatment
* Chronic treatment with NSAIDs
* Concomitant treatment with aminoglycoside antibiotics,etacrynic acid
18 Years
ALL
No
Sponsors
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Ferrer Internacional S.A.
INDUSTRY
Responsible Party
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ferrer
Principal Investigators
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Antonio Coca, MD, PhD
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Manuel Anguita, MD, PhD
Role: STUDY_CHAIR
Hospital Reina Sofia - Córdoba
Eduardo De Teresa, MD, PhD
Role: STUDY_CHAIR
Hospital Clinico - Málaga
Alfonso Castro Beiras, MD, PhD
Role: STUDY_CHAIR
Hospital Juan Canalejo - Coruña
Javier Díez
Role: STUDY_DIRECTOR
Centro Investigación Médica Aplicada (CIMA) - Pamplona (Navarra)
Locations
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Clinc Hospital
Barcelona, Barcelona, Spain
Germans Trias i Pujol Hospital
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
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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EudraCT number 2006-001446-14
Identifier Type: -
Identifier Source: secondary_id
N/GF-TORAFIC-06
Identifier Type: -
Identifier Source: org_study_id
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