Follow-up study of the long-term efficacy and safety of investigator-initiated clinical trials (HUCV002-01-02 study and HUCV002-01-03 study) of intravenous HUCV002-01 in patients with chronic heart failure (HUCV002-01-02 study and HUCV002-01-03 study)

Follow-up study of the long-term efficacy and safety of investigator-initiated clinical trials (HUCV002-01-02 study and HUCV002-01-03 study) of intravenous HUCV002-01 in patients with chronic heart failure.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1070220091

Enrollment

Registered

2023-01-18

Start date

2023-01-18

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

chronic heart failure heart failure, cardiomyopathy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who voluntarily participated in the preceding investigator-initiated clinical trial (protocol number: Study HUCV002-01-02 or Study HUCV002-01-03) and were administered the investigational product. 2)Patients who has ability to understand and sign the informed consent

Exclusion criteria

Exclusion criteria: 1) Patients whom the PI or investigators decided as inappropriate for the study.

Design outcomes

Primary

Measure	Time frame
Long-term safety (serious adverse effects and serious malfunction)	—

Secondary

Measure	Time frame
1) Cardiac function , 2) Events up to 2 years after the first administration of HUCV002-01 in chronic heart failure 1) Cardiac function: NYHA, LVEF, BNP or NT-proBNP 2) Events	—

Contacts

Public ContactMasataka Ikeda

Kyushu University Hospital

ikeda.masataka.850@m.kyushu-u.ac.jp+81-92-642-5360

Outcome results