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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Torasemide Prolonged Release
Furosemide
Sponsored by
Ferrer Internacional S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Chronic heart failure, Torasemide prolonged release, Myocardial fibrosis, Loop diuretics, Peptide of procollagen type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Hospital
  • Canet de Mar, Primary Care Centre
  • Centelles - Primar Care Centre
  • El Maresme - Primary Care Centre
  • Remei, Primary care centre
  • Begonte - Primary Care Centre
  • Clinico Universitario Virgen de la Victoria
  • Donostia Hospital
  • Alcover - primary care centre
  • Clinc Hospital
  • Germans Trias i Pujol Hospital
  • H. del Mar
  • Valle Hebrón Hospital
  • Reina Sofia Hospital
  • Josep Trueta Hospital
  • San Jorge Hospital
  • Complejo Hospitalario Juan Canalejo
  • Gregorio Marañón Hospital
  • Virgen de la Arrixaca
  • Clinico Universitario Hospital
  • Clinico Universitario de Santiago
  • General Hospital
  • Clinico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Torasemide prolonged released

Furosemide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
December 11, 2006
Last Updated
July 14, 2009
Sponsor
Ferrer Internacional S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00409942
Brief Title
Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
Acronym
TORAFIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferrer Internacional S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Chronic heart failure, Torasemide prolonged release, Myocardial fibrosis, Loop diuretics, Peptide of procollagen type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Torasemide prolonged released
Arm Title
2
Arm Type
Active Comparator
Arm Description
Furosemide
Intervention Type
Drug
Intervention Name(s)
Torasemide Prolonged Release
Other Intervention Name(s)
Torasemide Prolonged release:Sutril neo
Intervention Description
Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Furosemide: Seguril
Intervention Description
Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
Primary Outcome Measure Information:
Title
Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure)
Time Frame
8 months
Title
Cardiovascular events
Time Frame
8 months
Title
NT-proBNP (Brain Natriuretic Peptide)
Time Frame
8 months
Title
Hospitalizations, home care due to cardiovascular causes related to heart failure
Time Frame
8 months
Title
Safety and tolerability
Time Frame
8 months
Title
Quality of Life (Minnesota Test)
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Coca, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Manuel Anguita, MD, PhD
Organizational Affiliation
Hospital Reina Sofia - Córdoba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eduardo De Teresa, MD, PhD
Organizational Affiliation
Hospital Clinico - Málaga
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alfonso Castro Beiras, MD, PhD
Organizational Affiliation
Hospital Juan Canalejo - Coruña
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Javier Díez
Organizational Affiliation
Centro Investigación Médica Aplicada (CIMA) - Pamplona (Navarra)
Official's Role
Study Director
Facility Information:
Facility Name
Central Hospital
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Canet de Mar, Primary Care Centre
City
Canet de Mar
State/Province
Barcelona
Country
Spain
Facility Name
Centelles - Primar Care Centre
City
Centellas
State/Province
Barcelona
Country
Spain
Facility Name
El Maresme - Primary Care Centre
City
Mataró
State/Province
Barcelona
Country
Spain
Facility Name
Remei, Primary care centre
City
Vic
State/Province
Barcelona
Country
Spain
Facility Name
Begonte - Primary Care Centre
City
Begonte
State/Province
Lugo
Country
Spain
Facility Name
Clinico Universitario Virgen de la Victoria
City
Málaga
State/Province
Malaga
Country
Spain
Facility Name
Donostia Hospital
City
Donostia
State/Province
San Sebastián
Country
Spain
Facility Name
Alcover - primary care centre
City
Alcover
State/Province
Tarragona
Country
Spain
Facility Name
Clinc Hospital
City
Barcelona
Country
Spain
Facility Name
Germans Trias i Pujol Hospital
City
Barcelona
Country
Spain
Facility Name
H. del Mar
City
Barcelona
Country
Spain
Facility Name
Valle Hebrón Hospital
City
Barcelona
Country
Spain
Facility Name
Reina Sofia Hospital
City
Córdoba
Country
Spain
Facility Name
Josep Trueta Hospital
City
Girona
Country
Spain
Facility Name
San Jorge Hospital
City
Huesca
Country
Spain
Facility Name
Complejo Hospitalario Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
Gregorio Marañón Hospital
City
Madrid
Country
Spain
Facility Name
Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Clinico Universitario Hospital
City
Salamanca
Country
Spain
Facility Name
Clinico Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
General Hospital
City
Valencia
Country
Spain
Facility Name
Clinico Universitario
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15313958
Citation
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.
Results Reference
background
PubMed Identifier
16046900
Citation
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.
Results Reference
background
PubMed Identifier
15172408
Citation
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.
Results Reference
background
PubMed Identifier
16003166
Citation
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.
Results Reference
background
PubMed Identifier
17719472
Citation
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.
Results Reference
background
PubMed Identifier
21906812
Citation
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.
Results Reference
derived
PubMed Identifier
19673667
Citation
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.
Results Reference
derived

Learn more about this trial

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

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