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Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia.

Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia. - Examination of optimal patient endpoints in developing new therapeutic drugs for symptomatic bradycardia.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057029
Enrollment
80
Registered
2025-04-01
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

bradyarrhythmia

Interventions

None listed

Sponsors

National Cerebral and Cardiovascular Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who provided written informed consent for study 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: Sinus node dysfunction: 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, shortness of breath, decreased exercise tolerance, dizziness, lightheadedness, syncope, falls, dyspnea, chest pain, nausea, psychological burden due to the above symptoms.

Exclusion criteria

Exclusion criteria: 1) Patients with the following conditions or a history thereof: Moderate or severe aortic valve or mitral valve disease. Thyroid dysfunction. Ischemic heart disease (including myocardial infarction). Myocardial diseases such as cardiomyopathy. Patients with currently active malignant tumors or those who completed treatment for malignant tumors less than 5 years ago. 2) Patients with active infections requiring systemic treatment. 3) Patients with psychiatric disorders that pose problems for follow-up or compliance with the study protocol. 4) Other patients deemed inappropriate by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Changes in various quality of life indices before and after pacemaker implantation.

Countries

Japan

Contacts

Public ContactYoshihiro Asano

National Cerebral and Cardiovascular Center Genome Medicine Support Department

asano.yoshihiro@ncvc.go.jp06-6170-1070

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026