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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

Page last updated: August 23, 2015

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