![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000019236 |
Receipt No. | R000022142 |
Scientific Title | Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy. |
Date of disclosure of the study information | 2015/10/05 |
Last modified on | 2019/03/08 |
Basic information | ||
Public title | Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy. | |
Acronym | Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy. | |
Scientific Title | Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy. | |
Scientific Title:Acronym | Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy. | |
Region |
|
Condition | ||
Condition | Dilated cardiomyopathy | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safeness of Patient-Specific Cardiac Support Net to prevent the progression of left ventricular remodeling in dilated cardiomyopathy. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | End Point; The evaluation of the safeness during 24 weeks after implantation of this device.
New treatment added by heart failure exacerbation, and another performing of cardiac surgery. All-cause mortality, cardiac death.(death due to heart failure exacerbation) all adverse events. Device trouble. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | Cardiac Support Net | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1) Patients who sign the consent form of participating clinical study by their free will
2) Patients whose age are 20 years old or more, and 75 years or less at the time of obtaining informed consent 3) Patients with heart failure symptoms in spite of optimal drug oral treatment for heart failure (ACEI, ARB, diuretics, beta-blockers,oral cardiotonic, etc.) of more than 3 months 4) Patients whom NYHA classification is III or IV, or level of INTERMACS Profile is 4 to 7 5) Patients with LVEDD >= 60mm or LVEDDi >= 30mm/m2 in echocardiography 6) Patients with LVEF <= 35% in echocardiography 7) Patients with RVEDVi <= 170mL/m2 by MRI or CT analysis 8) Patients with walking distance of 6 minutes <= 450m 9) Patients who have the intention of follow-up examination and observation, and can be admitted to visit the hospital which carries out them |
|||
Key exclusion criteria | 1)Patients with excessively enlarged heart(LVEDD>85mm)
2)Patients with extremely low LVEF(<10%) 3)Patients with history of cardiac surgeryexcept pacemaker implantation. 4)Patients who are scheduled for other cardiac surgery 5)Patients with the history or the schedule of CABG 6)Patients with the history or candidate of PCI or trans myocardial laser revascularization within 3 months 7)Patients who are implementing the IABP 8)Patients who are adapted to left ventricular assist devices or scheduled heart transplant 9)Patients with the history or schedule for ICD/CRT within 3 months 10)Patients whose life expectancy 1 year or less 11)Heart failure patients in end stage whose surgery risk is unacceptably high 12)Patients who have developed acute myocardial infarction, unstable angina within 3 months 13)Patients with hypertrophic cardiomyopathy 14)Patient with active infection 15)Patients with severe liver dysfunction whose AST or ALT values are more than 5 times of normal range in their institute. 16)Patients with poor lung function (FEV-1 is less than 50%) 17)Patients with severe renal failure (serum creatinine is 3 mg/dL or more) or patients with dialysis-dependent 18)Patients with diffuse peripheral vascular disease 19)Patients with history of cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) within 3 months 20)Patients with a high degree of bleeding tendency 21)Patients with blood clotting disorders (patients with contraindicated for antithrombotic treatment) 22)Patients who refuse blood transfusion 23)Patients with poor prognosis by malignant diseases 24)Patients with severe dementia, drug addiction, alcoholism 25)Patients with severe allergy 26)Pregnant or nursing patients. Patients who do not agree with contraception during the study 27)Patients participating in other studies 28)Patients whom the investigator determine unsuitable for participation |
|||
Target sample size | 8 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Nagoya University School of Medicine | ||||||
Division name | Cardiac Surgery | ||||||
Zip code | |||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi | ||||||
TEL | 052-744-2376 | ||||||
takita@med.nagoya-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Nagoya University School of Medicine | ||||||
Division name | Cardiac Surgery | ||||||
Zip code | |||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi | ||||||
TEL | 052-744-2376 | ||||||
Homepage URL | |||||||
takita@med.nagoya-u.ac.jp |
Sponsor | |
Institute | Nagoya University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Osaka University Hospital, Tohoku University Hospital, Jikei University,Nagago unversity |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 大阪大学医学部附属病院(大阪府)、東北大学医学部附属病院(宮城県)、東京慈恵会医科大学附属病院(東京)、 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
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 | Terminated | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022142 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |