Pilot Study on the Efficacy and Safety of Nifekalant Cocktail for Atrial Flutter

Pilot Study on the Efficacy and Safety of Nifekalant Cocktail for Atrial Flutter - Pilot Study on the Efficacy and Safety of Nifekalant Cocktail for Atrial Flutter

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053787

Enrollment

Registered

2024-03-07

Start date

2022-01-21

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

Atrial flutter

Interventions

In patients with atrial flutter, administer 2g of magnesium sulfate via intravenous infusion over a period of 15 minutes, followed by an intravenous administration of 0.3mg/kg of Nifekalant over 5 min

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients presenting with persistent symptomatic atrial flutter at the time of evaluation.

Exclusion criteria

Exclusion criteria: Individuals exhibiting any of the following conditions: 1. QTc interval >=470 msec 2. Advanced atrioventricular block 3. Systolic blood pressure <90 mmHg 4. eGFR <15 mL/min/1.73m2 5. Severe hepatic impairment 6. Intracardiac thrombus 7. Pregnancy 8. Lack of consent to participate in the study

Design outcomes

Primary

Measure	Time frame
Primary effective outcome: termination of atrial flutter Primary safety outcome: adverse effects including Torsade de pointes	—

Countries

Japan

Contacts

Public ContactAkinori Sairaku

National Hospital Organization Higashihiroshima Medical Center Cardiology

rjrgw059@ybb.ne.jp082-423-2176

Outcome results

None listed

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