ECHO IRIS

CÓDIGO DEL ESTUDIO: CL2-44121-003 y CL2-44121-004

Nº EUDRACT: 2009-011558-16

DESCRIPCIÓN: Evaluación de los efectos de cuatro dosis orales (250, 500, 750, o 1000 mg b.i.d.) de S 44121 versus placebo en péptido natri urético cerebral y función cardiaca en pacientes con insuficiencia cardiaca crónica y disfunción ventricular izquierda. Estudio multicéntrico, internacional, randomizado, doble ciego, grupo paralelo de 12 semanas de duración.

CRITERIOS DE INCLUSIÓN:

  • Male or female outpatients,
  • Aged ³ 18 years (or having reached majority if the legal age of majority is over 18 years) and £ 75 years,
  • Symptomatic chronic heart failure in NYHA functional class III since at least 3 months before selection,
  • Ischemic disease or idiopathic dilated cardiomyopathy as etiology for heart failure,
  • Left ventricular systolic dysfunction as evidenced by a LVEF £ 35 % as measured within 12 months before or at selection by either echocardiography, radionuclide ventriculography, magnetic resonance imaging, cardiac angiography, or computed tomography angiography,
  • Documented hospital admission for worsening of heart failure within XX weeks before selection,
  • Treated with a beta-blocker since at least 6 months before selection,
  • Treated with an ACE inhibitor and/or an ARB since at least 6 months before selection,
  • Treated with optimal and unchanged CHF treatment and dosages since at least 4 weeks before selection,
  • Ability to perform a 6-Minute Walk Test,
  • Informed consent obtained.

CRITERIOS DE EXCLUSIÓN:

  • Legal incapacity or limited legal incapacity,
  • Women who are pregnant (verified before inclusion by an urinary pregnancy test in all women except in women hysterectomized, menopaused for more than 2 years, or sterilized),
  • Women who are breast-feeding,
  • Women of childbearing potential not using estro-progestative or progestative or intrauterine contraception, or women using estro-progestative or progestative or intra-uterine contraception, but who consider stopping it during the planned duration of the study,
  • Participation in another drug or device trial at the same time or within the previous
  •  30 days before selection. Marketed drugs used for unapproved indications are considered to be investigational drugs,
  • Particpant already enrolled in the study.

 Medical and therapeutic criteria:

  • Unstable condition within the previous 4 weeks before selection (e.g. unstable heartfailure symptomatology or a documented hospital admission due to worsening of chronic heart failure),
  • Recent (less than 2 months before selection) myocardial infarction or coronary
  • revascularisation,
  • History of stroke or cerebral transient ischemic attack within the previous 4 weeks before selection,
  • Chronic heart failure secondary to any of the following conditions:

- Severe aortic or mitral stenosis, severe aortic regurgitation, or severe primary mitral

- regurgitation,

- Congenital heart disease,

- Hypertension,

- Pericardial disease,

- Non-cardiac disease (e.g., uncorrected thyroid disease).

  • Scheduled surgery for valvular heart disease,
  • Scheduled revascularisation (PCI or CABG),
  • Active myocarditis,
  • Previous cardiac transplantation or on list for cardiac transplantation,
  • Cardiac resynchronisation therapy (CRT) started within the previous 6 months,
  • Permanent atrial fibrillation or flutter,
  • Severe or uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg),
  • Systolic blood pressure < 90 mmHg,
  • History of severe obstructive or restrictive chronic pulmonary disease,
  • Known carriers of hepatitis B surface antigen, hepatitis C virus antibodies or human immunodeficiency virus antibodies,
  • Known alcohol or drug abuse,
  • Treatment which is unauthorised during the study or patient for whom such a treatment is considered,
  • Known hereditary problems of lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption [if study drug contains lactose],
  • Any serious disease likely to interfere with the conduct of the study.

ESQUEMA DE ACTUACIÓN:

RESPONSABLES DEL ESTUDIO:

I.P.: Dr. Sellés

Promotor: Servier

CRO: Servier

TELÉFONO DE DUDAS:

Monitora: Patricia Caballero (639204984)

 

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