JPRN-jRCT2051210177Active, not recruitingPhase 2
Phase IIb/III Clinical Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy
Akita Yasuhiko0 sites60 target enrollmentStarted: February 19, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Patients with a confirmed diagnosis of idiopathic TGCV and who are least 18 years of age at time of informed consent.
Exclusion 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.
Investigators
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