UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057500 |
|---|---|
| Receipt number | R000064976 |
| Scientific Title | Efficacy of Cardiac Resynchronization Therapy in Patients with Non-Left Bundle Branch Block type ECG: Multicenter Registry |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2026/04/05 15:26:14 |
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Basic information
Public title
Efficacy of Cardiac Resynchronization Therapy in Patients with Non-Left Bundle Branch Block type ECG: Multicenter Registry
Acronym
non-LBBB CRT Study
Scientific Title
Efficacy of Cardiac Resynchronization Therapy in Patients with Non-Left Bundle Branch Block type ECG: Multicenter Registry
Scientific Title:Acronym
non-LBBB CRT Study
Region
| Japan |
Condition
Condition
Heart failure patients with non-left bundle branch block type ECG who meet the class IIa/IIb recommendation for cardiac resynchronization therapy (CRT) according to the Japanese guideline on non-pharmacological therapy of cardiac arrhythmias
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the Japanese guidelines, the indication for cardiac resynchronization therapy (CRT) in heart failure patients with reduced left ventricular ejection fraction (EF <=35%, HFrEF) and non-left bundle branch block (non-LBBB) ECG is classified as Class IIa for a QRS duration >=150 msec and Class IIb for a QRS duration between 120 msec and 149 msec. However, clinical evidence on CRT in this population are largely limited. This study aims to evaluate the efficacy of CRT in Japanese HFrEF patients with non-LBBB ECG.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The criteria for CRT responders (LVEF, LVESV, Clinical Composite Score)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient's age should be 20 y/o or more at the time of consent acquisition.
2. Therapeutic indication of cardiac resynchronization therapy should be based on the Japanese guideline (2018 JCS/JHRS non-pharmacological guideline).
3. QRS morphology should not meet the Strauss's criteria for left bundle branch block (LBBB).
Strauss's Criteria for LBBB:
1. Intrinsic QRS duration >140 ms (men) or >130 ms (women).
2. QS or rS pattern in leads V1 and V2.
3. Notching or slurring in the mid-QRS complex in at least two of the following leads: V1, V2, V5, V6, I, and aVL.
Key exclusion criteria
1. Patients who meet Class III indication of CRT in the Japanese guideline.
2. Patients with frequent recurrent ventricular tachycardia (VT) or ventricular fibrillation (VF) that cannot be controlled with antiarrhythmic drugs or catheter ablation.
3. Patients with severe drug-refractory congestive heart failure classified as NYHA functional class IV who are not candidates for heart transplantation, cardiac resynchronization therapy (CRT), or left ventricular assist device.
4. Patients who have refused the rPatients who have refused the registration to this study.
5. Patients who are made ineligible for this study by physicians.
6. Patients who have LBBB type ECG based on the Strauss's criteria.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Harada |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
4701192
Address
1-98 Dengakugakugo Kutsukakcho Toyoake Aichi Japan
TEL
0562932312
mharada@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Harada |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
4701192
Address
1-98 Dengakugakugo Kutsukakcho Toyoake Aichi Japan
TEL
0562932312
Homepage URL
mharada@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Certified Review Board
Address
1-98 Dengakugakugo Kutsukakcho Toyoake Aichi Japan
Tel
0562932865
crb-f@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients who underwent CRT as of 29/March/2019 (after publication of the JCS/JHRS non-pharmacological guidelines) and completed the clinical follow-up before 31/Dec/2025 will be retrospectively enrolled.
Management information
Registered date
| 2025 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064976
