A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

CompletadoFase 2ClinicalTrials.gov

ID: NCT03016325Tipo: INTERVENTIONALInicio: 13 de ene de 2017Fin estimado: 12 de nov de 2019

Traducción no disponible, mostrando original

Resumen

A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Actively being hospitalized for acute decompensated heart failure
At least 1 administration of IV diuretic for the current episode
Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II
Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic
Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%

Criterios de exclusión

Systolic blood pressure \<105mm Hg or \>160mm Hg or heart rate \<50 or \>130 bpm
Have an active infection requiring IV anti-microbial treatment
Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening
Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening
Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)

Intervenciones

drug

HNO Donor

Infusion

drug

Placebo

Infusion

Ubicaciones

Local Institution

CABA, Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Corrientes, Argentina

Local Institution

Córdoba, Argentina

Local Institution

Córdoba, Argentina

Local Institution

Córdoba, Argentina

Local Institution

Córdoba, Argentina

Local Institution

Córdoba, Argentina

Local Institution

Santa Fe, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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