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CompletedNCT00409942TORAFICUpdated Jul 15, 2009

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

A Phase 4 interventional study of Torasemide Prolonged Release and Furosemide in Congestive Heart Failure, sponsored by Ferrer Internacional S.A.. Completed at 23 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-15.

Sponsored by Ferrer Internacional S.A. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
142
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Congestive Heart Failure

Keywords

  • Chronic heart failure
  • Torasemide prolonged release
  • Myocardial fibrosis
  • Loop diuretics
  • Peptide of procollagen type 1
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 142 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Ferrer Internacional S.A. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    1

    Torasemide prolonged released

    Drug: Torasemide Prolonged Release

  • Active comparator
    2

    Furosemide

    Drug: Furosemide

Interventions

  • DrugTorasemide Prolonged Release

    Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months

    Also known as: Torasemide Prolonged release:Sutril neo

  • DrugFurosemide

    Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months

    Also known as: Furosemide: Seguril

06

What researchers measure

Primary outcomes

  1. Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.

    Time frame: 8 months

Secondary outcomes

  1. Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure)

    Time frame: 8 months

  2. Cardiovascular events

    Time frame: 8 months

  3. NT-proBNP (Brain Natriuretic Peptide)

    Time frame: 8 months

  4. Hospitalizations, home care due to cardiovascular causes related to heart failure

    Time frame: 8 months

  5. Safety and tolerability

    Time frame: 8 months

  6. Quality of Life (Minnesota Test)

    Time frame: 8 months

07

Study locations

23 sites
  • 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
08

References and documents

Publications

  • Querejeta R, Lopez B, Gonzalez A, Sanchez E, Larman M, Martinez Ubago JL, Diez 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. doi: 10.1161/01.CIR.0000140973.60992.9A. Epub 2004 Aug 16. PubMed 15313958 ↗
  • Gonzalez A, Lopez B, Diez J. New directions in the assessment and treatment of hypertensive heart disease. Curr Opin Nephrol Hypertens. 2005 Sep;14(5):428-34. doi: 10.1097/01.mnh.0000174143.30045.bd. PubMed 16046900 ↗
  • Lopez B, Querejeta R, Gonzalez A, Sanchez E, Larman M, Diez 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. doi: 10.1016/j.jacc.2003.12.052. PubMed 15172408 ↗
  • Lopez B, Gonzalez A, Querejeta R, Diez J. The use of collagen-derived serum peptides for the clinical assessment of hypertensive heart disease. J Hypertens. 2005 Aug;23(8):1445-51. doi: 10.1097/01.hjh.0000173780.67308.f1. PubMed 16003166 ↗
  • Lopez B, Gonzalez A, Beaumont J, Querejeta R, Larman M, Diez 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. doi: 10.1016/j.jacc.2007.04.080. Epub 2007 Aug 13. PubMed 17719472 ↗
  • TORAFIC Investigators Group. Effects of prolonged-release torasemide versus furosemide on myocardial fibrosis in hypertensive patients with chronic heart failure: a randomized, blinded-end point, active-controlled study. Clin Ther. 2011 Sep;33(9):1204-1213.e3. doi: 10.1016/j.clinthera.2011.08.006. Epub 2011 Sep 8. PubMed 21906812 ↗
  • Diez J, Coca A, de Teresa E, Anguita M, Castro-Beiras A, Conthe P, Cobo E, Fernandez E; TORAFIC Investigators Group. TORAFIC study protocol: torasemide prolonged release versus furosemide in patients with chronic heart failure. Expert Rev Cardiovasc Ther. 2009 Aug;7(8):897-904. doi: 10.1586/erc.09.74. PubMed 19673667 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00409942
Lead sponsor
Ferrer Internacional S.A.
First posted
Dec 12, 2006
Start date
Mar 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Jul 15, 2009

Study contacts

Antonio Coca, MD, PhD
study chair · Hospital Clinic of Barcelona
Manuel Anguita, MD, PhD
study chair · Hospital Reina Sofia - Córdoba
Eduardo De Teresa, MD, PhD
study chair · Hospital Clinico - Málaga
Alfonso Castro Beiras, MD, PhD
study chair · Hospital Juan Canalejo - Coruña
Javier Díez
study director · Centro Investigación Médica Aplicada (CIMA) - Pamplona (Navarra)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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