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Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker

Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker - Observational study of patients with angiotensin receptor neprilysin inhibitor pacemaker

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000048443
Enrollment
200
Registered
2022-07-28
Start date
2022-08-01
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

HT Af

Interventions

None listed

Sponsors

Department of Cardiology University Northern Yokohama Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: HT After pacemaker implantation

Exclusion criteria

Exclusion criteria: (1) When the research subject requests discontinuation. (2) When the research is interrupted for reasons attributable to the research subject (e.g., moving, changing doctors or hospitals, busy schedule, inability to follow up, etc.) (3) When it is found that the research subject is not a target case after the research has begun. (4) In the event of an accidental incident (5) When an adverse event occurs (including exacerbation of the underlying disease, complications, or accident) and the investigator determines that the study should be terminated (6) When it becomes difficult to continue the research due to inadequate efficacy or worsening of symptoms (7) When there is a serious deviation from the research protocol and it is judged that the research cannot be evaluated (8) When it is found that the research subject is not taking the medication as instructed by the physician in charge of the research (9) Other cases in which the investigator determines that the continuation of the research is difficult and that discontinuation is appropriate.

Design outcomes

Primary

MeasureTime frame
Time to atrial fibrillation onset

Secondary

MeasureTime frame
Atrial fibrillation 6, 12, 18, 24 months after surgery Change in parameters AP VP battery voltage A, Vlead resistance, threshold, wave height AFburden at 24 months after pacemaker implantation Total number of supraventricular extrasystoles Supraventricular extrasystoles short run atrial tachycardia 6,12,18,24 months after surgery Change from baseline in resting heart rate 6, 12, 18, and 24 months after surgery Change from baseline in the following biochemical tests 6,12,18,24 months after surgery Neutral fat, LDL,HDL cholesterol, fatty acid quartiles, hemoglobin, hematocrit, cystatin C, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, NT-pro BNP

Countries

Japan

Contacts

Public Contactmorio ono

Showa University Northern Yokohama Hospital Cardiology

morio.ono@gmail.com0459497000

Outcome results

None listed

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