Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
TORAFIC
Prospective, Randomised, Open, Blinded-endpoint Study of Torasemide Prolonged Release vs Furosemide to Evaluate the Efficacy on Myocardial Fibrosis in Patients With Heart Failure
2 other identifiers
interventional
142
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2007
Typical duration for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2006
CompletedFirst Posted
Study publicly available on registry
December 12, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJuly 15, 2009
June 1, 2009
2.3 years
December 11, 2006
July 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
8 months
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALTorasemide prolonged released
2
ACTIVE COMPARATORFurosemide
Interventions
Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
Related Publications (7)
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.
PMID: 15313958BACKGROUNDGonzalez 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.
PMID: 16046900BACKGROUNDLopez 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.
PMID: 15172408BACKGROUNDLopez 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.
PMID: 16003166BACKGROUNDLopez 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.
PMID: 17719472BACKGROUNDTORAFIC 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.
PMID: 21906812DERIVEDDiez 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.
PMID: 19673667DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Antonio Coca, MD, PhD
Hospital Clinic of 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)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 11, 2006
First Posted
December 12, 2006
Study Start
March 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 15, 2009
Record last verified: 2009-06