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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017025
Receipt No. R000019744
Scientific Title Clinical Validation of a Novel Echo-Doppler Model to Predict Left-Sided Filling Pressure in Patients with Heart Failure
Date of disclosure of the study information 2015/04/03
Last modified on 2017/10/03

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Basic information
Public title Clinical Validation of a Novel Echo-Doppler Model to Predict Left-Sided Filling Pressure in Patients with Heart Failure
Acronym New Echo-Doppler Model for Heart Failure
Scientific Title Clinical Validation of a Novel Echo-Doppler Model to Predict Left-Sided Filling Pressure in Patients with Heart Failure
Scientific Title:Acronym New Echo-Doppler Model for Heart Failure
Region
Japan

Condition
Condition Heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate new model to predict pulmonary artery wedge pressure (PCWP) in patients with heart failure (HF), and to examine whether inferior vena cava diameter (IVCD)
corrected by ST/SM (IVCD X ST/SM) is a noninvasive and reliable predictor for PCWP
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The predictive value of new model for the accurate estimation of PCWP
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 Aged 20 years or older admitted to
our institution with a diagnosis of HF, who underwent right heart catheterization (RHC) and echocardiography
Key exclusion criteria History of valve replacement, receiving the mechanical support, shunt disease
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Yasuda
Organization National Cerebral and Cardiovascular Center
Division name Cardiovascular Medicine
Zip code
Address 5-7-1, Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Email yasuda.satoshi.hp@mail.ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Nagai
Organization National Cerebral and Cardiovascular Center
Division name Cardiovascular Medicine
Zip code
Address 5-7-1, Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Homepage URL
Email nagai@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 03 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 Enrolling by invitation
Date of protocol fixation
2013 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2015 Year 04 Month 02 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019744

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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