A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

CompletadoFase 4ClinicalTrials.gov

ID: NCT02661217Tipo: INTERVENTIONALInicio: 12 de feb de 2016Fin estimado: 20 de jun de 2018

Traducción no disponible, mostrando original

Resumen

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs \& Symptoms
Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
Meeting one of the following criteria:
Patients on any dose of ACEI or ARB at screening
ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening.

Criterios de exclusión

History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients.
Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
Serum potassium above 5.4 mmol/L at Randomization.
Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
Severe hepatic impairment, biliary cirrhosis and cholestasis

Intervenciones

drug

LCZ696

LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food. The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient.

Ubicaciones

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

Villa María, Córdoba Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Salta, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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