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

JRCT ID: jRCT2051210177

Registered date:19/02/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Idiopathic triglyceride deposit cardiomyovasculopathy
• Date of first enrollment: 03/03/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): CNT-01 or CNT-01 placebo is administered orally three times daily (in the morning, at noon, and in the evening). The starting dose of CNT-01 is 500 mg (1,500 mg/day) for the first 2 weeks, then the dose is increased to 1000 mg (3,000 mg/day).

Outcome(s)

• Primary Outcome: major adverse cardiovascular events

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with a confirmed diagnosis of idiopathic TGCV and who are least 18 years of age at time of informed consent.

Exclude criteria

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.

Related Information

• Primary Sponsor: Akita Yasuhiko