UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049998 |
|---|---|
| Receipt number | R000056947 |
| Scientific Title | Validation of right ventricular endomyocardial biopsy as a surrogate marker of left ventricular fibrosis in dilated cardiomyopathy |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2026/07/13 15:14:44 |
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Basic information
Public title
Validation of right ventricular endomyocardial biopsy as a surrogate marker of left ventricular fibrosis in dilated cardiomyopathy
Acronym
Biopsy as a surrogate maker for left ventricular fibrosis
Scientific Title
Validation of right ventricular endomyocardial biopsy as a surrogate marker of left ventricular fibrosis in dilated cardiomyopathy
Scientific Title:Acronym
Biopsy as a surrogate maker for left ventricular fibrosis
Region
| Japan |
Condition
Condition
dilated cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the extent of fibrosis on right ventricular (RV) endomyocardial biopsy (EMB) and left ventricular (LV) fibrosis on excised hearts, and to assess the correlation between RV-EMB and LV- fibrosis in dilated cardiomyopathy (DCM).
Basic objectives2
Others
Basic objectives -Others
Correlation analysis between histopathology and imaging diagnosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of right ventricular (RV) endocardial myocardial biopsy (EMB) histopathology with the degree of left ventricular (LV) fibrosis in explanted hearts that subsequently underwent pathologic dissection or heart transplantation.
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) Patients who have had pathological evaluation performed in the Pathology Department of our institution.
2) For autopsy cases, patients who had a right ventricular endocardial biopsy performed prior to death.
3) For heart transplant cases, patients who have undergone right ventricular endocardial biopsy prior to transplantation.
Key exclusion criteria
1) Patients with coronary artery disease, previous cardiac surgery (excluding assistive device implantation including LVAD), or apparent acute myocarditis.
2) Patients who have declared non-participation in the study after reading the opt-out document.
3) Patients who are deemed inappropriate by the Principal Investigator or the Principal Investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kinta |
| Middle name | |
| Last name | Hatakeyama |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pathology
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
+81-(6)6-6170-1070
kpathol@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kisaki |
| Middle name | |
| Last name | Amemiya |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pathology
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
+81-(6)6-6170-1070
Homepage URL
amemiya.kisaki@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
Tel
+81-(6)6170-1070
clinical.research.desk@ncvc.go.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
国立循環器病研究センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
doi: 10.1002/ehf2.14642.
Publication of results
Unpublished
Result
URL related to results and publications
doi: 10.1002/ehf2.14642.
Number of participants that the trial has enrolled
70
Results
Fibrosis in 70 RV-EMB from DCM was compared with whole cross-sectional LV of excised hearts (median interval: 4.1 years). Fibrosis area ratios were evaluated by image analysis. Septal LGE was classified into 4 categories. RV-EMB fibrosis correlated significantly with excised LV (r=0.82, P<0.0001) and diffuse LGE (r=0.71, P=0.003). In multivariate analysis adjusted for interval, RV-EMB fibrosis remained strongly associated with LV fibrosis (coefficient: 0.82, P<0.0001).
Results date posted
| 2026 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
retrospective, single-centre, nonrandomised, subserial observational study examined patients with DCM who underwent heart transplantation or autopsy at the National Cerebral and Cardiovascular Center in Japan to determine whether RV-EMB specimens correspond to LV fibrosis in transplanted or autopsied heart. We included all patients with ventricular dilation and systolic dysfunction without coronary artery disease who underwent RV-EMB before heart transplantation or autopsy and were ultimately diagnosed with DCM by histologically excluding secondary cardiomyopathy. Initially, we reviewed data from 59 patients with DCM who received heart transplantation for severe heart failure symptoms unresponsive to maximal pharmacological therapy or mechanical support and 72 DCM patients who underwent autopsy between November 1981 and December 2021 to determine the cause of death.
Participant flow
Four patients who had undergone cardiac intervention (1 case of coronary artery bypass surgery, 1 case of percutaneous coronary intervention, 2 cases of mitral valve replacement) after EMB were excluded. We also excluded 57 patients who had not undergone EMB at diagnosis and finally included 70 cases (52 explanted hearts for heart transplant and 18 autopsy cases) to correlate RV fibrosis in EMB with LV fibrosis in explanted hearts in the same patients. Nine (50%) of 18 autopsied cases had been registered or considered for heart transplantation before death. The causes of death among all autopsied cases were attributed to worsening heart failure.
Adverse events
None
Outcome measures
The median interval between biopsy and excision was 4.1 years. The fibrosis area ratio of excised hearts were evaluated via image analysis. The distribution of cardiovascular magnetic resonance late gadolinium enhancement in the intraventricular septum was classified into four quartile categories.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine the relationship between right ventricular endocardial myocardial biopsy histopathology and the extent of left ventricular fibrosis in explanted hearts that subsequently underwent pathologic dissection or heart transplantation.
Management information
Registered date
| 2023 | Year | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056947
