Symptomatic Bradyarrhythmias therapy,drug therapy
Conditions
Interventions
Sponsors
Asano Yoshihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactSayaka Doyama
The University of Osaka Hospital
Outcome results
None listed