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

July 14, 2009 updated by: Ferrer Internacional S.A.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • H. del Mar
      • Barcelona, Spain
        • Clinc Hospital
      • Barcelona, Spain
        • Germans Trias I Pujol Hospital
      • Barcelona, Spain
        • Valle Hebrón Hospital
      • Córdoba, Spain
        • Reina Sofía Hospital
      • Girona, Spain
        • Josep Trueta Hospital
      • Huesca, Spain
        • San Jorge Hospital
      • La Coruña, Spain
        • Complejo Hospitalario Juan Canalejo
      • Madrid, Spain
        • Gregorio Marañon hospital
      • Murcia, Spain
        • Virgen de la Arrixaca
      • Salamanca, Spain
        • Clinico Universitario Hospital
      • Santiago de Compostela, Spain
        • Clinico Universitario de Santiago
      • Valencia, Spain
        • General Hospital
      • Zaragoza, Spain
        • Clinico Universitario
    • Asturias
      • Oviedo, Asturias, Spain
        • Central Hospital
    • Barcelona
      • Canet de Mar, Barcelona, Spain
        • Canet de Mar, Primary Care Centre
      • Centellas, Barcelona, Spain
        • Centelles - Primar Care Centre
      • Mataró, Barcelona, Spain
        • El Maresme - Primary Care Centre
      • Vic, Barcelona, Spain
        • Remei, Primary care centre
    • Lugo
      • Begonte, Lugo, Spain
        • Begonte - Primary Care Centre
    • Malaga
      • Málaga, Malaga, Spain
        • Clinico Universitario Virgen de la Victoria
    • San Sebastián
      • Donostia, San Sebastián, Spain
        • Donostia Hospital
    • Tarragona
      • Alcover, Tarragona, Spain
        • Alcover - primary care centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure)
Time Frame: 8 months
8 months
Cardiovascular events
Time Frame: 8 months
8 months
NT-proBNP (Brain Natriuretic Peptide)
Time Frame: 8 months
8 months
Hospitalizations, home care due to cardiovascular causes related to heart failure
Time Frame: 8 months
8 months
Safety and tolerability
Time Frame: 8 months
8 months
Quality of Life (Minnesota Test)
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 11, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 12, 2006

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/GF-TORAFIC-06
  • EudraCT number 2006-001446-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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