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Completed

NCT Number: NCT00409942

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

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinc Hospital, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Torasemide Prolonged Release

Drug

Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months

Other names: Torasemide Prolonged release:Sutril neo

Furosemide

Drug

Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months

Other names: Furosemide: Seguril

Primary outcomes

  1. Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.

    Time frame: 8 months

Secondary outcomes

  1. Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure)

    Time frame: 8 months

  2. Cardiovascular events

    Time frame: 8 months

  3. NT-proBNP (Brain Natriuretic Peptide)

    Time frame: 8 months

  4. Hospitalizations, home care due to cardiovascular causes related to heart failure

    Time frame: 8 months

  5. Safety and tolerability

    Time frame: 8 months

  6. Quality of Life (Minnesota Test)

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Ferrer Internacional S.A.

Industry

Registry information

Official study 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

Acronym: TORAFIC

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 12, 2006
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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