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

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Drug: Torasemide Prolonged Release Drug: Furosemide	Phase IV

MedlinePlus related topics:

Heart Failure

Drug Information available for:

Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Torsemide Furosemide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy 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

Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:

Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Cardiovascular events [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
NT-proBNP (Brain Natriuretic Peptide) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Hospitalizations, home care due to cardiovascular causes related to heart failure [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Safety and tolerability [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
Quality of Life (Minnesota Test) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	142
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Torasemide prolonged released	Drug: Torasemide Prolonged Release Torasemide Prolonged release 10mg/day up to 40mg/day, treatment duration:8 months
2: Active Comparator Furosemide	Drug: Furosemide Furosemide 40mg/day up to 160mg/day, Treatment duration:8 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409942

Contacts


Contact: Ester Fernandez, MD	0034936003728	efernandez@ferrergrupo.com

Contact: Savion Gropper, MD	0034935093243	sgropper-research@ferrerrgupo.com

Locations


Spain
	Clinc Hospital	Recruiting
	Barcelona, Spain
	Principal Investigator: Antonio Coca, MD, PhD
	Sub-Investigator: Eulalia Roig, MD, PhD
	Valle Hebrón Hospital	Recruiting
	Barcelona, Spain
	Principal Investigator: Enrique Galve, MD, Phd
	Germans Trias i Pujol Hospital	Recruiting
	Barcelona, Spain
	Principal Investigator: Josep Lupón, MD
	H. del Mar	Active, not recruiting
	Barcelona, Spain
	Gregorio Marañón Hospital	Not yet recruiting
	Madrid, Spain
	Principal Investigator: Fernández Avilés
	San Jorge Hospital	Not yet recruiting
	Huesca, Spain
	Principal Investigator: Jesús Cebollada, MD
	Complejo Hospitalario Juan Canalejo	Recruiting
	La Coruña, Spain
	Principal Investigator: Lorenzo Montserrat, MD, PhD
	Reina Sofia Hospital	Recruiting
	Córdoba, Spain
	Principal Investigator: Manuel Anguita, MD, PhD
	Virgen de la Arrixaca	Recruiting
	Murcia, Spain
	Principal Investigator: Domingo Pascual, MD, PhD
	Clinico Universitario Hospital	Recruiting
	Salamanca, Spain
	Principal Investigator: Cándido Martin Luengo, Md, PhD
	Clinico Universitario de Santiago	Recruiting
	Santiago de Compostela, Spain
	Principal Investigator: Jose Ramón González Juanatey, MD, PhD
	General Hospital	Recruiting
	Valencia, Spain
	Principal Investigator: Francisco Ridocci, MD, PhD
	Clinico Universitario	Recruiting
	Zaragoza, Spain
	Principal Investigator: Juan Pérez, MD, PhD

Spain, Asturias
	Central Hospital	Recruiting
	Oviedo, Asturias, Spain
	Principal Investigator: Beatriz Díaz, MD, PhD

Spain, Malaga
	Clinico Universitario Virgen de la Victoria	Recruiting
	Málaga, Malaga, Spain
	Principal Investigator: Manuel Jiménez, MD, PhD

Spain, San Sebastián
	Donostia Hospital	Recruiting
	Donostia, San Sebastián, Spain
	Principal Investigator: Ramón Querejeta, MD, PhD

Sponsors and Collaborators

Ferrer Internacional S.A.

Investigators


Study Chair:	Antonio Coca, MD, PhD	Hospital Clinic - Barcelona

Study Chair:	Pedro Conthe, MD, PhD	Hospital Gregorio Marañón

Study Chair:	Manuel Anguita, MD, PhD	Hospital Reina Sofia - Córdoba

Study Chair:	Eduardo De Teresa, MD, PhD	Hospital Clinico - Málaga

Study Chair:	Alfonso Castro Beiras, MD, PhD	Hospital Juan Canalejo - Coruña

Study Director:	Javier Díez	Centro Investigación Médica Aplicada (CIMA) - Pamplona (Navarra)

More Information

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. Epub 2004 Aug 16.

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. Review.

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.

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. Review.

Responsible Party:	ferrer ( Savion Gropper )
Study ID Numbers:	N/GF-TORAFIC-06, EudraCT number 2006-001446-14
First Received:	December 11, 2006
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00409942
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Ferrer Internacional S.A.:

Chronic heart failure

Torasemide prolonged release

Myocardial fibrosis

Loop diuretics

Peptide of procollagen type 1

Study placed in the following topic categories:

Naphazoline

Oxymetazoline

Heart Failure

Heart Diseases

Guaifenesin

Phenylephrine

Fibrosis

Torsemide

Phenylpropanolamine

Furosemide

Additional relevant MeSH terms:

Membrane Transport Modulators

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Natriuretic Agents

Therapeutic Uses

Physiological Effects of Drugs

Diuretics

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Sodium Potassium Chloride Symporter Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Ferrer Internacional S.A.
Information provided by:	Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:	NCT00409942