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

未提供0 个研究点目标入组 50 人开始时间: 待定

适应症

试验速览

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•Patients who have provided written informed consent for trial participation of their own free will.
•Patients aged 18 years or older but under 80 years at the time of consent acquisition.
•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.
•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.
•Patients who can initiate study drug administration within 3 days of undergoing a new pacemaker implantation procedure.

•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
•Patients with an implantable cardioverter-defibrillator (ICD)
•Patients currently taking cilostazol or theophylline
•Patients who started any of the following medications within 3 months prior to screening:
•1 Amiodarone
•Patients who underwent catheter ablation within 3 months prior to screening
•Patients with active infections requiring systemic treatment
•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

发起方

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