Skip to content

Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy.

Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy. - Phase IIa trial of CNT-01 for patients with idiopathic triglyceride deposit cardiomyovasculopathy.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035403
Enrollment
20
Registered
2018-12-29
Start date
2018-12-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic triglyceride deposit cardiomyovasculopathy (TGCV).

Interventions

CNT-01(500mg), Oral, 3/day, 8weeks Placebo (control), Oral, 3/day, 8weeks

Sponsors

Osaka university hospital
Lead Sponsor
Aichi medical university hosiptal Juntendo university hospital Chiba university hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who have definite diagnosis of idiopathic TGCV. 2) BMIPP washout rate is less than 5% 3) Patients who walk for 6 minutes walking distance less than 400 m 4) Patients who got adequate explanation and understanding to participate in this trial and document consent by the individual 5) Patients whose age is over 20 years at the time of consent acquisition 6) Patients who can be taken orally

Exclusion criteria

Exclusion criteria: 1) Patients within 1 month of revascularization of coronary arteries 2) Patients with fasting serum capric acid concentration> 10 umol / L 3) Patients who had diet therapy containing medium chain fatty acid even once in the past 4) Patients with diabetic ketoacidosis 5) A pregnant patient, a pregnant woman or a lactating patient 6) Class IV patients with NYHA cardiac function classification 7) Patients with acute coronary syndrome 8) Patients with a history of drug addiction 9) Patients who are allergic to the ingredients of the CNT-01 10) Patients who are allergic to BMIPP or iodine 11) Patients with a history of clinically important drug allergic symptoms 12) Patients with severe liver dysfunction (Child-Pugh classifications B or C) 13) Patients who took part in other clinical trial studies within 3 months 14) Patients judged unsuitable for inclusion in this clinical trial

Design outcomes

Primary

MeasureTime frame
Change in 6-minute walking distance (m) 8 weeks after administration.

Countries

Japan

Contacts

Public ContactDaisaku Nakatani

Osaka University Hospital Medical innovation

nakatani@cardiology.med.osaka-u.ac.jp06-6210-8289

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026