Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure. (TORAFIC)

This study has been completed.
Sponsor:
Information provided by:
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT00409942
First received: December 11, 2006
Last updated: July 14, 2009
Last verified: June 2009
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 18, 2014