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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
History of Changes

December 11, 2006
July 14, 2009
March 2007
June 2009   (final data collection date for primary outcome measure)
Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
Complete list of historical versions of study NCT00409942 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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)
Not Provided
Not Provided
 
Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
Prospective, Randomised, Open, Blinded-endpoint Study of Torasemide Prolonged Release vs Furosemide to Evaluate the Efficacy on Myocardial Fibrosis in Patients With Heart Failure

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Congestive Heart Failure
  • Drug: Torasemide Prolonged Release
    Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
    Other Name: Torasemide Prolonged release:Sutril neo
  • Drug: Furosemide
    Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
    Other Name: Furosemide: Seguril
  • Experimental: 1
    Torasemide prolonged released
    Intervention: Drug: Torasemide Prolonged Release
  • Active Comparator: 2
    Furosemide
    Intervention: Drug: Furosemide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00409942
N/GF-TORAFIC-06, EudraCT number 2006-001446-14
No
Savion Gropper, ferrer
Ferrer Internacional S.A.
Not Provided
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)
Ferrer Internacional S.A.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP