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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: Torasemide Prolonged Release
  • Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
• Drug: Furosemide
  • Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Torasemide prolonged released
• Active Comparator: 2
  • Furosemide

Primary Measures

• Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
  • Time Frame: 8 months
    Safety Issue?: No

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ferrer Internacional S.A.

Overall Clinical Trial Officials and Contacts

Antonio Coca, MD, PhD Study Chair Hospital Clinic - Barcelona  

Overall Contact: Ester Fernandez, MD 0034936003728 efernandez@ferrergrupo.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00409942

Study ID Number: N/GF-TORAFIC-06

ClinicalTrials.gov Identifier: NCT00409942

Health Authority: Spain: Spanish Agency of Medicines