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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030723
Receipt No. 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

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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
Email 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
Email t.hayashi@med.hokucai.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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