Evaluating the Plasma Pharmacokinetics of CRD-102 in patients with Heart Failure following long term administration

Cardiora Pty Ltd0 个研究点目标入组 45 人开始时间: 2016年2月3日最近更新: 2020年1月13日

研究概览

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•1.Subject is at least 18 years of age
•2.HF consistent with NYHA class II - IV
•3.Subject has a known history of HF (more than 12 months in duration) and had at least 1 hospitalization for HF in the past 3 months
•4.Subject has left ventricular ejection fraction (LVEF) less than 35%
•5.Subject is receiving optimal medical therapy as tolerated according to the subject’s physician

•1. subject has had a myocardial infarct (MI) within 90 days before Screening
•2.Subject is listed for heart transplant or a LVAD
•3.Subject has a systolic blood pressure less than 90 mm Hg
•4.Subject has, at Screening, significant hepatic disease (serum total bilirubin equal or more than 3.0 mg/dL [equal or more than 51.3 micromol/L), renal disease (eGFR less than 30 mL/min), or hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease
•5.Subject is symptomatically too unwell to be considered for trial, as evidenced by 6MWT less than 150m
•6.Subject has undergone cardiac surgery within the 60 days before Screening
•7.Symptomatic ventricular arrhythmia or ICD firing within 60 days before Screening
•8.Subjects who are receiving flecainide, encainide, propafenone, dofetilide, or disopyramide
•9.Subjects who have received within 7 days before the Screening or dosing visits:
•a.An IV positive inotropic agent
•b.A human B-type natriuretic peptide, including nesiritide
•c.An oral or IV phosphodiesterase III inhibitor (PDEI III), including levosimendan and cilostazol
•10.Subjects who have the following laboratory results at screening
•a.Serum potassium concentration less than 4.0 or more than 5.5 mEq/L (less than 4.0 or more than 5.5 mmol/L)
•b.Serum magnesium concentration less than 1.0 mEq/L (less than 0.5 mmol/L)
•c.Serum digoxin concentration more than 1.2 ng/mL (more than 1.5 nmol/L)

发起方

Cardiora Pty Ltd