Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure. - Full Text View

Sponsor:	Ferrer Internacional S.A.
Information provided by:	Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:	NCT00409942

Purpose

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
Congestive Heart Failure	Drug: Torasemide Prolonged Release Drug: Furosemide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Furosemide Torsemide

U.S. FDA Resources

Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:

Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Cardiovascular events [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
NT-proBNP (Brain Natriuretic Peptide) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Hospitalizations, home care due to cardiovascular causes related to heart failure [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Safety and tolerability [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Quality of Life (Minnesota Test) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

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
Experimental: 1 Torasemide prolonged released	Drug: Torasemide Prolonged Release Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months Other Name: Torasemide Prolonged release:Sutril neo
Active Comparator: 2 Furosemide	Drug: Furosemide Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months Other Name: Furosemide: Seguril

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409942

Locations

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
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

Sponsors and Collaborators

Ferrer Internacional S.A.

Investigators

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)

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

TORAFIC 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. Epub 2011 Sep 8.

Díez J, Coca A, de Teresa E, Anguita M, Castro-Beiras A, Conthe P, Cobo E, Fernández 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.

Responsible Party:	Savion Gropper, ferrer
ClinicalTrials.gov Identifier:	NCT00409942 History of Changes
Other Study ID Numbers:	N/GF-TORAFIC-06, EudraCT number 2006-001446-14
Study First Received:	December 11, 2006
Last Updated:	July 14, 2009
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Ferrer Internacional S.A.:

Chronic heart failure
Torasemide prolonged release
Myocardial fibrosis
Loop diuretics
Peptide of procollagen type 1

Additional relevant MeSH terms:

Fibrosis
Heart Failure
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Furosemide
Torsemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 09, 2012