UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030723 |
|---|---|
| Receipt number | R000035077 |
| Scientific Title | Multicenter prospective study on usefulness of left ventricular global strain for the estimation of left ventricular filling pressure and the prediction of prognosis for patients with heart failure (SMAP II study) |
| Date of disclosure of the study information | 2018/01/08 |
| Last modified on | 2018/01/08 09:30:51 |
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Basic information
Public title
Multicenter prospective study on usefulness of left ventricular global strain for the estimation of left ventricular filling pressure and the prediction of prognosis for patients with heart failure (SMAP II study)
Acronym
Multicenter prospective study on usefulness of left ventricular global strain for the estimation of left ventricular filling pressure and the prediction of prognosis for patients with heart failure (SMAP II study)
Scientific Title
Multicenter prospective study on usefulness of left ventricular global strain for the estimation of left ventricular filling pressure and the prediction of prognosis for patients with heart failure (SMAP II study)
Scientific Title:Acronym
Multicenter prospective study on usefulness of left ventricular global strain for the estimation of left ventricular filling pressure and the prediction of prognosis for patients with heart failure (SMAP II study)
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) The aim of the present study is to re-examine the correlation between LV filling pressure and E/GLS, to examine the prognostic value of E/GLS, and to compare the diagnostic value of E/GLS for elevated LV filling pressure with that of tissue-Doppler index in the patients with various cardiovascular diseases.
(2) The aim of the present study is to re-examine the correlation between central venous pressure and inferior vena cava diameter in the patients with various cardiovascular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The relation between E/GLS and pulmonary artery wedge pressure, and between inferior vena cava diameter and central venous pressure.
Key secondary outcomes
(1) The relations between echocardiographic parameters and pulmonary artery wedge pressure.
(2) The relations between the cardiovascular events indicated below and each echocardiographic parameters.
A. total death
B. cardiovascular death
C. hospitalization due to cardiovascular events including heart failure
D. the elevation of the level of type-B natriuretic peptide
(3) The relations between echocardiographic parameters and pulmonary artery wedge pressure in specific subgroups, such as patients with certain diseases.
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 who will undergo right heart catheterization.
Key exclusion criteria
Patients with frequent supraventricular or ventricular premature contractions, those with moderate to severe mitral stenosis, those who underwent open heart surgery except for heart transplantation, and those who underwent hemodialysis.
Target sample size
332
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamada |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
syamada@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taichi Hayashi |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
t.hayashi@med.hokucai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
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
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
北海道大学病院（北海道）/Hokkaido Universigy Hospital、手稲渓仁会病院（北海道）/Teine Keijinkai Hospital、秋田大学（秋田県）/Akita University、筑波大学（茨城県）/University of Tsukuba、聖マリアンナ医科大学（神奈川県）/St.Marianna University School of Medicine、順天堂大学（東京都）/Juntendo University、慶應義塾大学（東京都）/Keio University、東京大学医学部附属病院（東京都）/the University of Tokyo Hospital、名古屋市立大学大学院（愛知県）/Nagoya City University Graduate School of Medical Sciences、三重大学大学院（三重県）/Mie University Graduate School of Medicine、兵庫県立姫路循環器病センター（兵庫県）/Hyogo Brain and Heart Center、徳島大学病院（徳島県）/Tokushima University Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not analyzed.
Management information
Registered date
| 2018 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035077
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