Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
Information source: Ferrer Internacional S.A.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure
Intervention: Torasemide Prolonged Release (Drug); Furosemide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ferrer Internacional S.A. Official(s) and/or principal investigator(s): Antonio Coca, MD, PhD, Study Chair, Affiliation: Hospital Clinic of Barcelona Manuel Anguita, MD, PhD, Study Chair, Affiliation: Hospital Reina Sofia - Córdoba Eduardo De Teresa, MD, PhD, Study Chair, Affiliation: Hospital Clinico - Málaga Alfonso Castro Beiras, MD, PhD, Study Chair, Affiliation: Hospital Juan Canalejo - Coruña Javier Díez, Study Director, Affiliation: Centro Investigación Médica Aplicada (CIMA) - Pamplona (Navarra)
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
Secondary outcome: Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure)Cardiovascular events NT-proBNP (Brain Natriuretic Peptide) Hospitalizations, home care due to cardiovascular causes related to heart failure Safety and tolerability Quality of Life (Minnesota Test)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Clinc Hospital, Barcelona, Spain
Germans Trias i Pujol Hospital, Barcelona, Spain
H. del Mar, Barcelona, Spain
Valle Hebrón Hospital, Barcelona, Spain
Reina Sofia Hospital, Córdoba, Spain
Josep Trueta Hospital, Girona, Spain
San Jorge Hospital, Huesca, Spain
Complejo Hospitalario Juan Canalejo, La Coruña, Spain
Gregorio Marañón Hospital, Madrid, Spain
Virgen de la Arrixaca, Murcia, Spain
Clinico Universitario Hospital, Salamanca, Spain
Clinico Universitario de Santiago, Santiago de Compostela, Spain
General Hospital, Valencia, Spain
Clinico Universitario, Zaragoza, Spain
Central Hospital, Oviedo, Asturias, 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
Begonte - Primary Care Centre, Begonte, Lugo, Spain
Clinico Universitario Virgen de la Victoria, Málaga, Malaga, Spain
Donostia Hospital, Donostia, San Sebastián, Spain
Alcover - primary care centre, Alcover, Tarragona, Spain
Additional Information
Related publications: Querejeta R, López B, González A, Sánchez E, Larman M, Martínez Ubago JL, Díez 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. Epub 2004 Aug 16. González A, López B, Díez J. New directions in the assessment and treatment of hypertensive heart disease. Curr Opin Nephrol Hypertens. 2005 Sep;14(5):428-34. Review. López B, Querejeta R, González A, Sánchez E, Larman M, Díez 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. López B, González A, Querejeta R, Díez J. The use of collagen-derived serum peptides for the clinical assessment of hypertensive heart disease. J Hypertens. 2005 Aug;23(8):1445-51. Review. López B, González A, Beaumont J, Querejeta R, Larman M, Díez 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. Epub 2007 Aug 13.
Starting date: March 2007
Last updated: July 14, 2009
|