Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
- Conditions
- Congestive Heart Failure
- Interventions
- Registration Number
- NCT00409942
- Lead Sponsor
- Ferrer Internacional S.A.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- Aged over 18
- 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
- Heart Failure due to aortic stenosis or hypertrophic myocardiopathy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Torasemide Prolonged Release Torasemide prolonged released 2 Furosemide Furosemide
- Primary Outcome Measures
Name Time Method Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. 8 months
- Secondary Outcome Measures
Name Time Method Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure) 8 months Cardiovascular events 8 months NT-proBNP (Brain Natriuretic Peptide) 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
Trial Locations
- Locations (23)
Central Hospital
🇪🇸Oviedo, Asturias, Spain
Centelles - Primar Care Centre
🇪🇸Centellas, Barcelona, Spain
San Jorge Hospital
🇪🇸Huesca, Spain
Virgen de la Arrixaca
🇪🇸Murcia, Spain
El Maresme - Primary Care Centre
🇪🇸Mataró, Barcelona, Spain
Remei, Primary care centre
🇪🇸Vic, Barcelona, Spain
Gregorio Marañón Hospital
🇪🇸Madrid, Spain
Reina Sofia Hospital
🇪🇸Córdoba, Spain
General Hospital
🇪🇸Valencia, Spain
Clinico Universitario Virgen de la Victoria
🇪🇸Málaga, Malaga, Spain
H. del Mar
🇪🇸Barcelona, Spain
Canet de Mar, Primary Care Centre
🇪🇸Canet de Mar, Barcelona, Spain
Alcover - primary care centre
🇪🇸Alcover, Tarragona, Spain
Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Clinico Universitario
🇪🇸Zaragoza, Spain
Valle Hebrón Hospital
🇪🇸Barcelona, Spain
Josep Trueta Hospital
🇪🇸Girona, Spain
Begonte - Primary Care Centre
🇪🇸Begonte, Lugo, Spain
Clinc Hospital
🇪🇸Barcelona, Spain
Germans Trias i Pujol Hospital
🇪🇸Barcelona, Spain
Donostia Hospital
🇪🇸Donostia, San Sebastián, Spain
Clinico Universitario Hospital
🇪🇸Salamanca, Spain
Complejo Hospitalario Juan Canalejo
🇪🇸La Coruña, Spain