Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00095238Tipo: INTERVENTIONALInicio: 1 de jun de 2002Fin estimado: 1 de jul de 2008

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.

Elegibilidad

Edad mínima: 60 YearsSexo: ALL

Criterios de inclusión

Male or female age \>= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
Left ventricular ejection fraction (LVEF) \> = 45%
Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.

Criterios de exclusión

Acute myocardial infarction within 3 months;
Heart revascularization procedure within 3 months;
Hospitalization for angina within 3 months;
Other heart surgery
Life-threatening or uncontrolled arrhythmia
Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;
Stroke or surgery of the arteries in the brain within 3 months;
Serious lung disease which requires use of home oxygen.
Significantly low blood pressure
Significantly high blood pressure
Other known diseases that may limit life expectancy to \<3 years;
Known or suspected bilateral kidney artery narrowing;
Geographic or social factors making study participation and follow-up impractical.

Intervenciones

drug

Irbesartan

Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

drug

Placebo

Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

San Martín, Buenos Aires, Argentina

Local Institution

Corrientes, Corrientes Province, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Mendoza, Mendoza Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorSanofi

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