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Congestive Heart FailurePhase 4TORAFICNCT00409942

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

A Phase 4 study testing Torasemide Prolonged Release and Furosemide in people with Congestive Heart Failure, run by Ferrer Internacional S.A. at 23 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Torasemide Prolonged Release and Furosemide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
23 sitesSpain
Study dates
Mar 2007to Jun 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 locations and contacts

23 sites in 1 country.

23 sites in 1 country

Spain23 sites

  • Complejo Hospitalario Juan Canalejo

    A Coruña, La Coruña

  • Alcover - primary care centre

    Alcover, Tarragona

  • Clinc Hospital

    Barcelona, Barcelona

  • Germans Trias i Pujol Hospital

    Barcelona, Barcelona

  • H. del Mar

    Barcelona, Barcelona

  • Valle Hebrón Hospital

    Barcelona, Barcelona

  • Begonte - Primary Care Centre

    Begonte, Lugo

  • Canet de Mar, Primary Care Centre

    Canet de Mar, Barcelona

  • Centelles - Primar Care Centre

    Centellas, Barcelona

  • Reina Sofia Hospital

    Córdoba, Córdoba

  • Donostia Hospital

    Donostia / San Sebastian, San Sebastián

  • Josep Trueta Hospital

    Girona, Girona

  • San Jorge Hospital

    Huesca, Huesca

  • Gregorio Marañón Hospital

    Madrid, Madrid

  • Clinico Universitario Virgen de la Victoria

    Málaga, Malaga

  • El Maresme - Primary Care Centre

    Mataró, Barcelona

  • Virgen de la Arrixaca

    Murcia, Murcia

  • Central Hospital

    Oviedo, Principality of Asturias

  • Clinico Universitario Hospital

    Salamanca, Salamanca

  • Clinico Universitario de Santiago

    Santiago de Compostela, Santiago de Compostela

  • General Hospital

    Valencia, Valencia

  • Remei, Primary care centre

    Vic, Barcelona

  • Clinico Universitario

    Zaragoza, Zaragoza

Other trials in Spain

About this study

Official 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

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.

Being tested
Torasemide Prolonged Release, Furosemide
Keywords
Chronic heart failure, Torasemide prolonged release, Myocardial fibrosis, Loop diuretics, Peptide of procollagen type 1
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Torasemide Prolonged ReleaseDrug

    Also called Torasemide Prolonged release:Sutril neo

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

  • FurosemideDrug

    Also called Furosemide: Seguril

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

Study groups in NCT00409942
Study groupRoleWhat they receive
1ExperimentalTorasemide prolonged released
Receives: Drug: Torasemide Prolonged Release
2Active comparatorFurosemide
Receives: Drug: Furosemide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 months

Secondary outcomes (6)

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

    Measured: 8 months

  2. Cardiovascular events

    Measured: 8 months

  3. NT-proBNP (Brain Natriuretic Peptide)

    Measured: 8 months

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

    Measured: 8 months

  5. Safety and tolerability

    Measured: 8 months

  6. Quality of Life (Minnesota Test)

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2006 (estimated)
  2. Study startMar 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00409942
Sponsor's protocol ID
N/GF-TORAFIC-06
Other IDs
EudraCT number 2006-001446-14
Acronym
TORAFIC
Status last verified
Jun 2009
First submitted
11 Dec 2006
Last updated
15 Jul 2009
Results posted
No
Data monitoring committee
No

Publications

  • Querejeta R, Lopez B, Gonzalez A, Sanchez E, Larman M, Martinez Ubago JL, Diez J. Increased collagen type I synthesis in patients with heart failure of hypertensive origin: relation to myocardial fibrosis. Circulation. 2004 Sep 7;110(10):1263-8. doi: 10.1161/01.CIR.0000140973.60992.9A. Epub 2004 Aug 16.

    PubMed 15313958

  • Gonzalez A, Lopez B, Diez J. New directions in the assessment and treatment of hypertensive heart disease. Curr Opin Nephrol Hypertens. 2005 Sep;14(5):428-34. doi: 10.1097/01.mnh.0000174143.30045.bd.

    PubMed 16046900

  • Lopez B, Querejeta R, Gonzalez A, Sanchez E, Larman M, Diez J. Effects of loop diuretics on myocardial fibrosis and collagen type I turnover in chronic heart failure. J Am Coll Cardiol. 2004 Jun 2;43(11):2028-35. doi: 10.1016/j.jacc.2003.12.052.

    PubMed 15172408

  • Lopez B, Gonzalez A, Querejeta R, Diez J. The use of collagen-derived serum peptides for the clinical assessment of hypertensive heart disease. J Hypertens. 2005 Aug;23(8):1445-51. doi: 10.1097/01.hjh.0000173780.67308.f1.

    PubMed 16003166

  • Lopez B, Gonzalez A, Beaumont J, Querejeta R, Larman M, Diez J. Identification of a potential cardiac antifibrotic mechanism of torasemide in patients with chronic heart failure. J Am Coll Cardiol. 2007 Aug 28;50(9):859-67. doi: 10.1016/j.jacc.2007.04.080. Epub 2007 Aug 13.

    PubMed 17719472

  • TORAFIC Investigators Group. Effects of prolonged-release torasemide versus furosemide on myocardial fibrosis in hypertensive patients with chronic heart failure: a randomized, blinded-end point, active-controlled study. Clin Ther. 2011 Sep;33(9):1204-1213.e3. doi: 10.1016/j.clinthera.2011.08.006. Epub 2011 Sep 8.

    PubMed 21906812

  • Diez J, Coca A, de Teresa E, Anguita M, Castro-Beiras A, Conthe P, Cobo E, Fernandez E; TORAFIC Investigators Group. TORAFIC study protocol: torasemide prolonged release versus furosemide in patients with chronic heart failure. Expert Rev Cardiovasc Ther. 2009 Aug;7(8):897-904. doi: 10.1586/erc.09.74.

    PubMed 19673667

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Torasemide Prolonged Release and Furosemide in people with Congestive Heart Failure, run by Ferrer Internacional S.A. at 23 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00409942, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2009.

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