Congestive Heart Failure
Conditions
Keywords
Chronic heart failure, Torasemide prolonged release, Myocardial fibrosis, Loop diuretics, Peptide of procollagen type 1
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.
Interventions
DRUGTorasemide Prolonged Release
Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
DRUGFurosemide
Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months
Sponsors
Ferrer Internacional S.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular events | 8 months |
| NT-proBNP (Brain Natriuretic Peptide) | 8 months |
| Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure) | 8 months |
| Safety and tolerability | 8 months |
| Quality of Life (Minnesota Test) | 8 months |
| Hospitalizations, home care due to cardiovascular causes related to heart failure | 8 months |
Countries
Spain
Outcome results
None listed