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A Double-Blind, Randomized, Placebo-Controlled Trial of NTC-801F in Patients with Symptomatic Bradyarrhythmias (Phase II)

A Double-Blind, Randomized, Placebo-Controlled Trial of NTC-801F in Patients with Symptomatic Bradyarrhythmias (Phase II)

Asano Yoshihiro

The University of Osaka Hospital

2-15, Yamadaoka, Suita-shi, Osaka Prefecture

asano.yoshihiro@ncvc.go.jp

Doyama Sayaka

The University of Osaka Hospital

2-15, Yamadaoka, Suita-shi, Osaka Prefecture, Japan

+81-6-6210-8289

801f-jimu@dmi.med.osaka-u.ac.jp

Pending

May. 18, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Patients who have provided written informed consent for trial participation of their own free will.
2) Patients aged 18 years or older but under 80 years at the time of consent acquisition.
3) Patients with any of the following bradyarrhythmias:
Sick sinus syndrome: Type I, Type II
Atrioventricular block: First degree, second degree or high-grade, and third degree
Bradyarrhythmic atrial fibrillation.
4) Patients with any of the following symptoms caused by bradyarrhythmia:
Fatigue, dyspnea, decreased exercise tolerance, dizziness, lightheadedness, syncope, falls, dyspnea, chest pain, nausea, psychological burden due to the above symptoms.
5) Patients who can initiate study drug administration within 3 days of undergoing a new pacemaker implantation procedure.

1) Patients with current or past history of the following conditions:
1 Moderate or greater aortic valve or mitral valve disease
2 Thyroid dysfunction
3 Ischemic heart disease (including myocardial infarction)
4 Cardiomyopathy or other myocardial disease
5 Patients with currently active malignant tumors or those less than 5 years post-completion of malignant tumor treatment
2) Patients with an implantable cardioverter-defibrillator (ICD)
3) Patients currently taking cilostazol or theophylline
4) Patients who started any of the following medications within 3 months prior to screening:
1 Amiodarone
2 Bepridil
5) Patients who underwent catheter ablation within 3 months prior to screening
6) Patients with active infections requiring systemic treatment
7) Patients with liver or kidney function exceeding the following criteria at screening:
1 AST: Exceeding 3 times the upper limit of the facility's reference range
2 ALT: Exceeding 3 times the upper limit of the facility's reference range
3 Total bilirubin: Exceeding 2 times the upper limit of the facility's reference range
4 Serum creatinine: Exceeding 2 times the upper limit of the facility's reference range, or eGFR <30 mL/min/1.73

Both

Symptomatic Bradyarrhythmias

drug therapy

therapy,drug therapy

KACh Channel Selective Inhibitor

D001919

D004358

Change in self-generated heart rate from baseline (HR/day) measured by 24-hour Holter ECG one week after investigational drug administration (DDD: 50 bpm + AV delay: 350 ms + mode switch on).

Efficacy)
1)Change in intrinsic atrial rate, PR interval, and ventricular rate at pacemaker checks at 1, 4, and 8 weeks after investigational drug administration.
2) Change in atrial and ventricular pacing rates at pacemaker checks at 1, 4, and 8 weeks after investigational drug administration.
3) Change in NTproBNP levels at 1, 4, and 8 weeks after investigational drug administration.
4) Change in cardiac ultrasound parameters at 1 and 8 weeks after investigational drug administration (TR-PG, LVDd, LVDs, LVEF, IVC diameter, LVESV, LVEDV, LVEDVi, LVESVi).
5) Change in spontaneous heart rate (HR/day) measured by 24-hour Holter ECG at 1 and 8 weeks after investigational drug administration.
6) Change in EQ-5D-5L score (comprehensive QOL score) at 8 weeks after investigational drug administration.
7) Change in KCCQ-12 score (heart failure QOL assessment score) at 8 weeks after investigational drug administration.
8) Change in NYHA score at 1, 4, and 8 weeks after investigational drug administration.
Safety)
For all subjects, the following items will be summarized from baseline to 8 weeks after investigational drug administration.
1) Incidence rate of adverse events and side effects.
2) QT/QTc interval on resting 12-lead ECG.
3) Frequency of ventricular arrhythmias and atrial fibrillation onset on Holter ECG monitoring.
4) Blood pressure values at 1, 4, and 8 weeks after investigational drug administration.
5) AST/ALT values at 1, 4, and 8 weeks after i nvestigational drugadministration.
6) eGFR values at 1, 4, and 8 weeks after investigational drug administration.
7) Cardiac-thoracic ratio on chest X-ray.

+81-6-6210-8289

Dec. 08, 2025

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