UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024698 |
|---|---|
| Receipt number | R000028416 |
| Scientific Title | Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery |
| Date of disclosure of the study information | 2016/11/10 |
| Last modified on | 2020/11/06 12:08:50 |
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Basic information
Public title
Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Acronym
Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Scientific Title
Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Scientific Title:Acronym
Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Region
| Japan |
Condition
Condition
Severe heart failure requiring left ventricular assist device
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the shapes of RV pressure-volume loops and RV stroke works between before and after equipping left ventricular assist device.
Basic objectives2
Others
Basic objectives -Others
We will assess right ventricular function by three-dimensional transesophageal echocardiography during left ventricular assist device surgery to construct new diagnostic criteria for right heart failure requiring right ventricular assist device.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Right ventricular stroke work, right ventricular stroke work index
Key secondary outcomes
right ventricular ejection fraction, right ventricular end-diastolic volume index, right ventricular end-systolic volume index, right ventricular stroke volume/right ventricular end-systolic volume
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
Patients requiring left ventricular assist device
Key exclusion criteria
contraindications of transesophageal echocardiography,
atrial fibrillation,
patients who have been equipped with PCPS ,
not obtained informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yoshitani |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesioogy
Zip code
564-8565
Address
6-1 Kishibe, Suita, Osaka
TEL
06-6170-1070
sohtamikaze@gmail.com
Public contact
Name of contact person
| 1st name | Eiki |
| Middle name | |
| Last name | Kanemaru |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesioogy
Zip code
236-0004
Address
3-9 Fukuura, Yokohama, Kanagawa
TEL
045-787-2800
Homepage URL
eiki-k.16@hotmail.co.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
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, Suita, Osaka
Tel
06-6170-1070
hec@ml.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
https://doi.org/10.1111/aor.13749
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/aor.13749
Number of participants that the trial has enrolled
22
Results
Right ventriculoarterial coupling increased significantly after LVAD implantation, suggesting that the efficiency of RV performance improved. Although RVSWI was similar between before and after LVAD implantation, the shape of the RV-PVC changed markedly after LVAD implantation. RVMWI increased significantly after LVAD implantation, corresponding to a significantly higher CI to match LVAD flow. These findings indicate that LVAD implantation might not worsen RV function.
Results date posted
| 2020 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The most common etiology of heart failure (HF) was dilated cardiomyopathy [n=14 (63.6%)]. LV ejection fraction of patients who underwent LVAD implantation was 16.5% (13.8-21.0). Most patients in this study were INTERMACS profile 3 (stable but inotrope-dependent) [n=13 (59.1%)].
Participant flow
Patients aged 20 years or older who underwent LVAD implantation for the first time (n=66) were eligible for this study. Patients with extracorporeal membrane oxygenation and intra-aortic balloon pumps were excluded because RV function could not be evaluated accurately. Patients with right ventricular assist device (RVAD) and LVAD implantation at the same time were excluded because RV function after LVAD implantation could not be evaluated. Patients with congenital heart disease were also excluded. In addition, patients whose 3D-TEE images could not be analysed using three-dimensional (3D) semi-automated software (Image Arena, version 4.6, and 4D RV function, version 1.2; Tomtec Imaging Systems GmbH, Unterschlesissheim, Germany) were excluded. Ultimately, we included 22 patients in the analysis.
Adverse events
none
Outcome measures
Ees/Ea, Ees, Ea, RVSWI, RVMWI, the shape of RV pressure-volume curve
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will also collect conventional data such as TAPSE(tricuspid annular plane systolic excursion), RVFAC(right ventricular fractional area change) and severity of TR.
Management information
Registered date
| 2016 | Year | 11 | Month | 03 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028416
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