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

Ferrer

Status and phase: Completed; Phase 4

Conditions: Congestive Heart Failure

Treatments: Drug: Furosemide; Drug: Torasemide Prolonged Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409942

N/GF-TORAFIC-06

EudraCT number 2006-001446-14

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

1

Experimental group

Description:

Torasemide prolonged released

Treatment:

Drug: Torasemide Prolonged Release

2

Active Comparator group

Description:

Furosemide

Treatment:

Drug: Furosemide