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Efficacy of closed loop stimulation pacing in patients with heart failure

Efficacy of closed loop stimulation pacing in patients with heart failure - closed loop simulation pacing-heart failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038879
Enrollment
30
Registered
2020-01-01
Start date
2018-02-01
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

chronic heart failure

Interventions

Activate closed loop stimulation Deactivate closed loop stimulation

Sponsors

Nippon Medical School Musashi-Kosugi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnosed with heart failure according to the ESC 2016 guidelines for the diagnosis and treatment of acute and chronic heart failure CRT-p or CRT-D is needed according to the JCS guidelines for the diagnosis and treatment of acute and chronic heart failure; patients who meet all the following criteria: Receiving optimal medical therapy, NYHA III/IV, sinus rhythm, LVEF(Left ventricular ejection fraction) less than 35%, Left bundle branch block (LBBB) with QRS interval greter than 130 msec Patients who has already implanted with CTT-P/CRT-D and also CLS is inactivated: patients who meet all the following criteria: NYHA II/III/IV, LBBB was documented at device was implated, medication was not changed last 3 months prior to enrollment Age 20 years or more Mental inability to perticipate

Exclusion criteria

Exclusion criteria: Used at enrollment or planned during study mechanical circulatory suppoft, including intraaortic balloon pumping, percutaneous cardiopulmonary suport, continuous hemodiafiltration, left ventricular assist device Acute coronary syndrome Planned cardiac surgery for heart failure Chronic kidney disease(Creatinene 2.5mg/dl or more) and maintenance dialysis Malignancy Pregnancy or possible pregnancy

Design outcomes

Primary

MeasureTime frame
1. The differences in NT-proBNP 2. The differences in Minnesota Living With Heart Failure Questionnaire

Secondary

MeasureTime frame
The differences in the following parameters during 6 months of closed loop stimulation 1.6-minute walking distance 2.variation in heart rate 3.New York Heart Association classification 4.cardiothoracic ratio 5.parameters in echocardiography 6.rehospitalization rate for acute exacerbation of heart failure, time to rehospitalization, all cause death, all cause rehospitalizatoin 7.kidney function including serum creatinine, eGFR, BUN 8.incidence of atrial fibrillation and its burden 9.percentage of atrial and ventricular pacing

Countries

Japan

Contacts

Public ContactIshihara Shiro

Nippon Medical School Musashi-Kosugi Hospital Department of Cardiology

s-ishihara@nms.ac.jp044-733-5181

Outcome results

None listed

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