Phase IIb/III Clinical Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy

TOA EIYO LTD.0 个研究点目标入组 60 人开始时间: 2022年3月3日最近更新: 2025年3月12日

试验速览

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•Patients with a confirmed diagnosis of idiopathic TGCV and who are least 18 years of age at time of informed consent.

•Patients with NYHA functional class I and both TGCV severity score ADL and symptom score of less than 10 points at the Baseline Visit.
•Patients who have a metabolic deficit of 50 % or more in the left ventricle (>=50 % LV, a defect score of 34 or more in the 17-segment model) detected by 123I-BMIPP myocardial scintigraphy (early image) at the Baseline Visit.
•Patients with a change in pharmacotherapy for heart disease or dyslipidemia within 3 months prior to the Baseline Visit, patients who have received non-pharmacotherapy for heart disease within 3 months prior to the Baseline Visit or who are scheduled to receive non-pharmacotherapy for heart disease during the study period.
•Patients with HbA1c >= 7.5 % (NGSP level) measured at the Screening Visit.
•Patients with LDL-cholesterol >= 120 mg/dL at the Screening Visit.
•Patients with a BMI of less than 17.0 or 35.0 or more at the Screening Visit.
•Patients who are pregnant, lactating, or possibly pregnant, or female patients who wish to become pregnant during the study period.

major adverse cardiovascular events

BMIPP WR
Vascular lumen volume in diffuse coronary atherosclerotic lesions
CT value of low density vessel wall volume in diffuse coronary atherosclerotic lesions
LVEF and LVEDV
Incidence of adverse events and adverse drug reactions
TGCV Severity Score
Plasma concentration of capric acid

发起方