Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
Information source: Ferrer Internacional S.A.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure
Intervention: Torasemide Prolonged Release (Drug); Furosemide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ferrer Internacional S.A. Official(s) and/or principal investigator(s):
Antonio Coca, MD, PhD, Study Chair, Affiliation: Hospital Clinic - Barcelona
Pedro Conthe, MD, PhD, Study Chair, Affiliation: Hospital Gregorio Marañón
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)
Overall contact:
Ester Fernandez, MD, Phone: 0034936003728, Email: efernandez@ferrergrupo.com
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: Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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
Ester Fernandez, MD, Phone: 0034936003728, Email: efernandez@ferrergrupo.com
Clinc Hospital, Barcelona, Spain; Recruiting
Antonio Coca, MD, PhD, Principal Investigator
Eulalia Roig, MD, PhD, Sub-Investigator
Valle Hebrón Hospital, Barcelona, Spain; Recruiting
Enrique Galve, MD, Phd, Principal Investigator
Germans Trias i Pujol Hospital, Barcelona, Spain; Recruiting
Josep Lupón, Phd, Principal Investigator
H. del Mar, Barcelona, Spain; Recruiting
Jordi Bruguera, MD, PhD, Principal Investigator
Passeig Sant Joan- Primary care Centre, Barcelona, Spain; Recruiting
Joan Canales, PhD, Principal Investigator
Reina Sofia Hospital, Córdoba, Spain; Recruiting
Manuel Anguita, MD, PhD, Principal Investigator
Josep Trueta Hospital, Girona, Spain; Recruiting
Julia Roure, MD, PhD
Julia Roure, MD, Phd, Principal Investigator
San Jorge Hospital, Huesca, Spain; Recruiting
Jesus Cebolladas, MD, PhD, Principal Investigator
Complejo Hospitalario Juan Canalejo, La Coruña, Spain; Recruiting
Lorenzo Montserrat, MD, PhD, Principal Investigator
Gregorio Marañón Hospital, Madrid, Spain; Recruiting
Pedro Luis Sanchez, Md, PhD, Principal Investigator
Puerta de Hierro Hospital, Madrid, Spain; Active, not recruiting
Virgen de la Arrixaca, Murcia, Spain; Recruiting
Domingo Pascual, MD, PhD, Principal Investigator
Clinico Universitario Hospital, Salamanca, Spain; Recruiting
Cándido Martin Luengo, Md, PhD, Principal Investigator
Clinico Universitario de Santiago, Santiago de Compostela, Spain; Recruiting
Jose Ramón González Juanatey, MD, PhD, Principal Investigator
General Hospital, Valencia, Spain; Recruiting
Francisco Ridocci, MD, PhD, Principal Investigator
Clinico Universitario, Zaragoza, Spain; Recruiting
Juan Pérez, MD, PhD, Principal Investigator
Central Hospital, Oviedo, Asturias, Spain; Recruiting
Beatriz Díaz, MD, PhD, Principal Investigator
El Maresme - Primary Care Centre, Mataró, Barcelona, Spain; Recruiting
Pere Torán, PhD, Principal Investigator
Canet de Mar, Primary Care Centre, Canet de Mar, Barcelona, Spain; Recruiting
Mar Rodríguez, PhD, Principal Investigator
Remei, Primary care centre, Vic, Barcelona, Spain; Recruiting
Manel Tern, PhD, Principal Investigator
Centelles - Primar Care Centre, Centelles, Barcelona, Spain; Active, not recruiting
Begonte - Primary Care Centre, Begonte, Lugo, Spain; Active, not recruiting
Clinico Universitario Virgen de la Victoria, Málaga, Malaga, Spain; Recruiting
Manuel Jiménez, MD, PhD, Principal Investigator
Meixoeiro Hospital, Vigo, Pontevedra, Spain; Active, not recruiting
Donostia Hospital, Donostia, San Sebastián, Spain; Recruiting
Ramón Querejeta, MD, PhD, Principal Investigator
Alcover - primary care centre, Alcover, Tarragona, Spain; Recruiting
Alejandro Rodríguez, Principal Investigator
Additional Information
Related publications: 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. 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. Review. 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. 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. 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
Ending date: March 2009
Last updated: October 23, 2008
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