Idiopathic Triglyceride Deposit Cardiomyovasculopathy
Conditions
Interventions
Patients will receive CNT-01 500 mg orally three times daily for 14 days. On Day 15, patients will take CNT-01 500 mg only once after blood drawing.
Sponsors
Ken-ichi Hirano, Department of Cardiovascular Medicine, Osaka University Grduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have a definite diagnosis of idiopathic triglyceride deposit cardiomyovasculopathy 2) After receiving a sufficient explanation upon participation in this study, on a full understanding, patients who obtained the written informed consent from each patient 3) More than 20 years old at the time of informed consent 4) Is able to oral intake 5) Must be willing to comply with protocol-required examination such as BMIPP myocardial scintigraphy
Exclusion criteria
Exclusion criteria: 1) Have diabetic ketoacidosis 2) Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years 3) Female with pregnant or lactating 4) Is not able to agree to using intrauterine device, oral contraceptive, condom or having sexual intercourse from the start of taking investigational product to 30 days after the end of the study 5) Have a New York Heart Association functional classification IV 6) Have a known history of drug dependence 7) Is allergic to any component of the investigational product 8) Is allergic to BMIPP or iodine 9) Have a known history of clinically significant drug allergy 10) Have a severe liver dysfunction (Child classification B and C) 11) Participated in other clinical study within the past 3 months and received an investigational agent including placebo 12) Being treated with diet containing medium chain fatty acid 13) Is considered unfit for the study by the Investigator's medical decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adverse event -Change in ECG parameters from Baseline (QTc, QT, QRS) -Change in vital signs from Baseline (Body temperature, Blood pressure, Pulse rate) -Change in clinical laboratory data from Baseline (Hematology, Serum chemistry, Urinalysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in uptake and washout rate in BMIPP myocardial scintigraphy -Change in blood concentration of fatty acid fraction from Baseline -Change in lipase activity in peripheral polynuclear leucocyte from Baseline -Change in blood lipoprotein fraction from Baseline (Total cholesterol in Chylomicron, VLDL, LDL, HDL, Triglyceride in Chylomicron, VLDL, LDL, HDL) -Change in vacuolation rate in polynuclear leucocyte from Baseline -Change in frequency in use of nitroglycerin from Baseline -Change in New York Heart Association (NYHA) functional classification from Baseline -Change in vascular endothelial function from Baseline (Reactive hyperemic index) -Change in score of SF-36 from Baseline | — |
Countries
Japan
Contacts
Public ContactDaisaku Nakatani
Osaka University Hospital Department of Medical Innovation
Outcome results
None listed