Post-marketing clinical trial of Sigmart; injection in patients with acute decompensated heart failure

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080221253

Enrollment

Registered

2010-09-28

Start date

2010-09-28

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

Acute decompensated heart failure:ADHF

Interventions

investigational material(s) Generic name etc : Sigmart(Nicorandil)injection INN of investigational material : Therapeutic category code : 217 Vasodilators Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ADHF patients ,written informed consent provided by patient or representative

Exclusion criteria

Exclusion criteria: Serious arrhythmia Contraindications for Sigmart® injection etc.

Design outcomes

Primary

Measure	Time frame
Composite of all-cause mortality and cardiovascular event from drug initiation through day 30 Comparison with control group	—

Secondary

Measure	Time frame
-Composite of all-cause mortality and cardiovascular event from drug initiation through day 180 -change of renal function -Efficacy -Safety Comparison with control group	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026