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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomised, Open, Blinded-endpoint Study of Torasemide Prolonged Release vs Furosemide to Evaluate the Efficacy on Myocardial Fibrosis in Patients With Heart Failure

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: Torasemide Prolonged Release
* Drug: Furosemide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Torasemide prolonged released | Drug: Torasemide Prolonged Release<br>* Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months<br>* Other names: Torasemide Prolonged release:Sutril neo;|
| Active Comparator: 2<br>Furosemide | Drug: Furosemide<br>* Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months<br>* Other names: Furosemide: Seguril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure) |  | 8 months | 
| Cardiovascular events |  | 8 months | 
| NT-proBNP (Brain Natriuretic Peptide) |  | 8 months | 
| Hospitalizations, home care due to cardiovascular causes related to heart failure |  | 8 months | 
| Safety and tolerability |  | 8 months | 
| Quality of Life (Minnesota Test) |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic heart failure, Torasemide prolonged release, Myocardial fibrosis, Loop diuretics, Peptide of procollagen type 1