A 36-week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

CompletadoFase 2ClinicalTrials.gov

ID: NCT00887588Tipo: INTERVENTIONALInicio: 1 de nov de 2009Fin estimado: 1 de dic de 2011

Traducción no disponible, mostrando original

Resumen

The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection fraction.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Patients with documented stable chronic heart failure (NYHA II-IV):
LVEF ≥ 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography)
the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction.
Plasma NT-proBNP \> 500 pg/ml at Visit 1.
Patients with documented stable chronic heart failure (NYHA II-IV).
Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit 1.
Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted).
Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2).
Patients with at least one of the following symptoms at the time of screening (Visit 1):
Dyspnea on exertion
Orthopnea
Paroxysmal nocturnal dyspnea
Peripheral edema
Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
Patients with a potassium ≤5.2 mmol/l at Visit 1.

Criterios de exclusión

Patients with a prior LVEF reading \<45%, at any time.
Patients who require treatment with both an ACE inhibitor and an ARB.
Isolated right heart failure due to pulmonary disease.
Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity.
Presence of hemodynamically significant mitral and /or aortic valve disease.
Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
Presence of hypertrophic obstructive cardiomyopathy.

Intervenciones

drug

LCZ696

50 mg, 100 mg and 200 mg tablets

drug

Valsartan

40 mg, 80 mg and 160 mg tablets

drug

Placebo

matching placebo to LCZ696 and Valsartan

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Ramos Mejía, Buenos Aires, Argentina

Novartis Investigative Site

San Martín, Buenos Aires, Argentina

Novartis Investigative Site

Corrientes, Corrientes Province, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Santa Fe, Santa Fe Province, Argentina

Novartis Investigative Site

Santa Fe, Santa Fe Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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