Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure. (TORAFIC)
This study has been completed.
Sponsor:
Ferrer Internacional S.A.
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure |
Drug: Torasemide Prolonged Release Drug: Furosemide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ferrer Internacional S.A.:
Primary Outcome Measures:
- Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 142 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Torasemide prolonged released
|
Drug: Torasemide Prolonged Release
Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
Other Name: Torasemide Prolonged release:Sutril neo
|
|
Active Comparator: 2
Furosemide
|
Drug: Furosemide
Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
Other Name: Furosemide: Seguril
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409942
Locations
| Spain | |
| 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 | |
Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
| 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) |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Savion Gropper, ferrer |
| ClinicalTrials.gov Identifier: | NCT00409942 History of Changes |
| Other Study ID Numbers: | N/GF-TORAFIC-06, EudraCT number 2006-001446-14 |
| Study First Received: | December 11, 2006 |
| Last Updated: | July 14, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Ferrer Internacional S.A.:
|
Chronic heart failure Torasemide prolonged release Myocardial fibrosis Loop diuretics Peptide of procollagen type 1 |
Additional relevant MeSH terms:
|
Fibrosis Heart Failure Pathologic Processes Heart Diseases Cardiovascular Diseases Furosemide Torsemide Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 21, 2013