None listed
Conditions
Interventions
Group 1 Type of group
aliskiren 75 mg OD, in forced titration at 150 mg OD, forced titration at 300 mg OD orally for 34 weeks
Group name:Group 2 Type of group
Placebo orally for 34 weeks
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Pacientes masculinos o femeninos de 18 o mas años de edad. • Pacientes dentro de 7-42 dias de un infarto agudo de miocardio asociado con disfuncion sistolica ventricular izquierda previo a la Visita 1 • Disfuncion sistolica ventricular izquierda documentada asociada con la calificacion obtenida de infarto agudo de miocardio por evaluacion clinica (estudio) despues de infarto del miocardio previo a Visita 1. • Los pacientes deberan estar en dosis estables, de las siguientes medicaciones concomitantes estandares de cuidado post infarto por al menos 2 semanas antes de la Visita 1 a menos que este contraindicado debido a intolerancia • Un paciente debe estar en una dosis estable basada en la evidencia de un inhibidor de la enzima convertidora de angiotensina (ACEI) o un bloqueador del receptor de angiotensina (ARB) pero no ambos, por al menos 2 semanas previas a la Visita 1, a menos de que este contraindicado debido a intolerancia. Para pacientes sin una dosis basada en una evidencia de un ACEI o ARB, la razon (Ej. paciente intolerante a estas medicaciones) debe ser documentada. • Pacientes que sean elegibles para participar en el estudio, y que consientan en hacerlo despues de haberseles explicado claramente el proposito y la naturaleza de la investigacion (consentimiento informado escrito)
Exclusion criteria
Exclusion criteria: • Patients who require a combination therapy of both: ACEI and ARB at Visit 1 or at any time during the study. • Hypertrophic cardiomyopathies due to other etiologies other than hypertension (eg, idiopathic or valvular). • Severe refractory hypertension defined as MSSBP> 180 mmHg and / or MSDBP> 110 mmhg) at Visit 2. • Stenotic lesions or hemodynamically significant valvular, subvalvular or supravalvular obstructive lesions. • Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infectious cardiomyopathy (eg, Chagas disease). • Cardiogenic shock or systolic BP 5.1 mEq / L, or dehydration in Visit 1 of the study. • Significant cardiovascular valvular disease that is expected to lead to cardiac surgery during the course of the study. • Unstable angina that requires intervention between Visit 1 and Visit 2. • Any coronary artery bypass procedure within 7 days prior to Visit 1. • CABG, PCI, CRT, LVAD or heart transplant planned or anticipated after the patient is enrolled in the study. • Current abuse or recent history of abuse of alcohol or other drugs in the past 12 months). • Significant non-cardiovascular disease or similar condition that results in death before completing the study, eg transplantation of a major organ (life expectancy 5 mlU / ml). • Woman with potential to procreate (WOCBP), defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation prevents their relationship with a male partner and women whose partners have been sterilized by vasectomy or other means unless they meet the following definition of postmenopause: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluated by echocardiography, from baseline to the end of the study Measure:Change in the left ventricular end systolic volume (LVESV) Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The event is recorded when it happens. Measure:Occurrence of CV death, hospitalization due to heart failure, or a reduction in ejection fraction greater than 6 units Timepoints:After treatment ; Outcome name:The event is recorded when it happens. Measure:Occurrence of CV death, hospitalization due to heart failure, recurrent MI, cerebrovascular accident or sudden resuscitated death Timepoints:After treatment | — |
Countries
Belgium, Denmark, Germany, Hungary, Italy, Netherlands, Peru, Sweden, United Kindgdom
Contacts
Public ContactSonia Silva
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed