Status:
COMPLETED
Effect of a New Formulation of Torasemide (Prolonged Release)on Myocardial Fibrosis in Patients With Heart Failure.
Lead Sponsor:
Ferrer Internacional S.A.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hype...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00409942
Start Date
March 1 2007
End Date
June 1 2009
Last Update
July 15 2009
Active Locations (23)
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1
Clinc Hospital
Barcelona, Barcelona, Spain
2
Germans Trias i Pujol Hospital
Barcelona, Barcelona, Spain
3
H. del Mar
Barcelona, Barcelona, Spain
4
Valle Hebrón Hospital
Barcelona, Barcelona, Spain