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Sponsored by: |
Ferrer Internacional S.A. |
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Information provided by: | Ferrer Internacional S.A. |
ClinicalTrials.gov Identifier: | NCT00409942 |
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.
Condition | Intervention | Phase |
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Congestive Heart Failure |
Drug: Torasemide Prolonged Release Drug: Furosemide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomised, Open, Blinded-endpoint Study of Torasemide Prolonged Release vs Furosemide to Evaluate the Efficacy on Myocardial Fibrosis in Patients With Heart Failure |
Enrollment: | 142 |
Study Start Date: | March 2007 |
Study Completion Date: | June 2009 |
Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Torasemide prolonged released
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Drug: Torasemide Prolonged Release
Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
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2: Active Comparator
Furosemide
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Drug: Furosemide
Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Clinc Hospital | |
Barcelona, Spain | |
Valle Hebrón Hospital | |
Barcelona, Spain | |
Germans Trias i Pujol Hospital | |
Barcelona, Spain | |
H. del Mar | |
Barcelona, Spain | |
Reina Sofia Hospital | |
Córdoba, Spain | |
Clinico Universitario Hospital | |
Salamanca, Spain | |
San Jorge Hospital | |
Huesca, Spain | |
Complejo Hospitalario Juan Canalejo | |
La Coruña, Spain | |
Gregorio Marañón Hospital | |
Madrid, Spain | |
Virgen de la Arrixaca | |
Murcia, Spain | |
Josep Trueta Hospital | |
Girona, Spain | |
Clinico Universitario de Santiago | |
Santiago de Compostela, Spain | |
General Hospital | |
Valencia, Spain | |
Clinico Universitario | |
Zaragoza, Spain | |
Spain, Asturias | |
Central Hospital | |
Oviedo, Asturias, Spain | |
Spain, Barcelona | |
El Maresme - Primary Care Centre | |
Mataró, Barcelona, Spain | |
Canet de Mar, Primary Care Centre | |
Canet de Mar, Barcelona, Spain | |
Remei, Primary care centre | |
Vic, Barcelona, Spain | |
Centelles - Primar Care Centre | |
Centellas, Barcelona, Spain | |
Spain, Lugo | |
Begonte - Primary Care Centre | |
Begonte, Lugo, Spain | |
Spain, Malaga | |
Clinico Universitario Virgen de la Victoria | |
Málaga, Malaga, Spain | |
Spain, San Sebastián | |
Donostia Hospital | |
Donostia, San Sebastián, Spain | |
Spain, Tarragona | |
Alcover - primary care centre | |
Alcover, Tarragona, Spain |
Study Chair: | Antonio Coca, MD, PhD | Hospital Clinic - 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 Director: | Javier Díez | Centro Investigación Médica Aplicada (CIMA) - Pamplona (Navarra) |
Responsible Party: | ferrer ( Savion Gropper ) |
Study ID Numbers: | N/GF-TORAFIC-06, EudraCT number 2006-001446-14 |
Study First Received: | December 11, 2006 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00409942 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Chronic heart failure Torasemide prolonged release Myocardial fibrosis Loop diuretics Peptide of procollagen type 1 |
Oxymetazoline Heart Failure Heart Diseases Phenylephrine Fibrosis Diuretics |
Torsemide Cardiovascular Agents Antihypertensive Agents Sodium Potassium Chloride Symporter Inhibitors Furosemide |
Heart Failure Heart Diseases Molecular Mechanisms of Pharmacological Action Fibrosis Physiological Effects of Drugs Diuretics Torsemide Cardiovascular Agents Antihypertensive Agents |
Furosemide Pharmacologic Actions Membrane Transport Modulators Pathologic Processes Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Sodium Potassium Chloride Symporter Inhibitors |