UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The stiffness of liver and spleen, velocity of inferior vena cava, and skip perfusion pressure in patients with heart failure.
Title of the study (Brief title)	Echo elastography, velocity of inferior vena cava, and skip perfusion pressure in patients with heart failure.
Region	Japan

Condition
Condition	Heart Failure
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the association between echo elastography, velocity of IVC, skin perfusion pressure and prognosis in patients with heart failure
Basic objectives2	Others
Basic objectives -Others	Observational
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiovascular death
Key secondary outcomes	Composite endpoint included all-cause death, cardiovascular death, and heart failure readmission and rates of each event. Serum BNP level.

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 were admitted our hospital Age greater than or equal to 20 years old Obtained written informed consent
Key exclusion criteria	(1) patients with liver cirrhosis (2) patients with dialysis (3) patients with acute coronary syndrome (4) patients with hematopoietic disorders (5) patients with portal hypertension (6) patients with acute viral infection (i.e. EB virus) (7) patients with splenomegaly due to infection (i.e. tuberculosis, malaria, and brucellosis) (8) patients with splenomegaly due to accumulation diseases (9) patients with splenomegaly due to autoimmune disorders (10) patients who can not be performed MRI (11) patients with arteriosclerosis obliterans in lower limb
Target sample size	100

Research contact person
Name of lead principal investigator	Toshitaka Okabe
Organization	Showa University Northern Yokohama Hospital
Division name	Division of Cardiology and Cardiac Catheterization Laboratories
Address	35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL	045-949-7000
Email	sunyh-hf@hotmail.com

Public contact
Name of contact person	Toshitaka Okabe
Organization	Showa University Northern Yokohama Hospital
Division name	Division of Cardiology and Cardiac Catheterization Laboratories
Address	35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL	045-949-7000
Homepage URL
Email	sunyh-hf@hotmail.com

Sponsor
Institute	Showa University Northern Yokohama Hospital
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)

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	2017 Year 11 Month 03 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 07 Month 05 Day
Anticipated trial start date	2017 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Follow up patients to evaluate mortality, cardiovascular event and laboratory data. By hospital visit or telephone contact.

Management information
Registered date	2017 Year 11 Month 03 Day
Last modified on	2018 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031726