Document Detail


TORAFIC study protocol: torasemide prolonged release versus furosemide in patients with chronic heart failure.
MedLine Citation:
PMID:  19673667     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
METHODS: This prospective, Phase IV, randomized, blinded end point, active-controlled clinical trial will randomize 142 patients with chronic heart failure in New York Heart Association functional class II-IV to 8 months treatment with either torasemide-PR (10-40 mg daily) or furosemide (40-160 mg daily). The primary objective is to test the hypothesis that torasemide-PR is superior to furosemide in reducing myocardial fibrosis. The primary outcome measure is the difference in the change of serum propeptide of procollagen type I concentration from the initial to the final visit between both study groups. Secondary outcome measures include all efficacy variables related to heart failure (signs and symptoms, ECG, echocardiogram and serum levels of N-terminal brain natriuretic propeptide). Secondary safety variables are heart rate, blood pressure, laboratory data, adverse events, cardiovascular events (hospital admission, emergency department visits) and quality of life (Minnesota questionnaire).
DISCUSSION: This trial will test whether torasemide-PR possesses antifibrotic properties, which may provide an additional benefit beyond diuresis in patients with chronic heart failure.
Authors:
Javier Díez; Antonio Coca; Eduardo de Teresa; Manuel Anguita; Alfonso Castro-Beiras; Pedro Conthe; Erik Cobo; Ester Fernández;
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Publication Detail:
Type:  Clinical Trial, Phase IV; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Expert review of cardiovascular therapy     Volume:  7     ISSN:  1744-8344     ISO Abbreviation:  Expert Rev Cardiovasc Ther     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-13     Completed Date:  2009-10-30     Revised Date:  2013-05-20    
Medline Journal Info:
Nlm Unique ID:  101182328     Medline TA:  Expert Rev Cardiovasc Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  897-904     Citation Subset:  IM    
Affiliation:
Division of Cardiovascular Sciences, Centre of Applied Medical Research, Department of Cardiology and Cardiovascular Surgery, University Clinic, Universidad de Navarra, Edificio CIMA, Avda. Pío XII 55, E-31008, Pamplona, Spain. jadimar@unav.es
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00409942
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MeSH Terms
Descriptor/Qualifier:
Chronic Disease
Collagen Type I / blood
Delayed-Action Preparations
Diuretics / administration & dosage,  therapeutic use*
Female
Fibrosis / drug therapy,  physiopathology
Furosemide / administration & dosage,  therapeutic use*
Heart Failure / drug therapy*,  physiopathology
Humans
Male
Peptide Fragments / blood
Procollagen / blood
Prospective Studies
Research Design
Sulfonamides / administration & dosage,  therapeutic use*
Chemical
Reg. No./Substance:
0/Collagen Type I; 0/Delayed-Action Preparations; 0/Diuretics; 0/Peptide Fragments; 0/Procollagen; 0/Sulfonamides; 0/procollagen type I carboxy terminal peptide; 54-31-9/Furosemide; 56211-40-6/torsemide
Investigator
Investigator/Affiliation:
Eulàlia Roig / ; Enrique Galve / ; Josep Lupón / ; Francisco Ridocci / ; Domingo Pascual / ; Pedro L Sánchez / ; Cándido Martín / ; Juan Ignacio Pérez-Calvo / ; Ramón Querejeta / ; Manuel Jiménez-Navarro / ; Lorenzo Monserrat / ; J R González-Juanatey / ; Beatriz Díaz / ; Jesús Cebollada / ; Julia Roure / ; Sonia Ruiz / ; Isidro López / ; Manel Terns / ; Silvia Narejos / ; Alex Rodríguez / ; Mar Rodríguez / ; Pere Toran /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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