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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018691
Receipt No. R000021637
Scientific Title Prospective Validation of Mathematical Expression for The Time to Cardiovascular Events using the Clinical Parameters in Patients with Heart Failure
Date of disclosure of the study information 2015/08/17
Last modified on 2016/09/06

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Basic information
Public title Prospective Validation of Mathematical Expression for The Time to Cardiovascular Events using the Clinical Parameters in Patients with Heart Failure
Acronym Mathematical Prediction of Prognosis for Patients with Heart Failure (PPP study)
Scientific Title Prospective Validation of Mathematical Expression for The Time to Cardiovascular Events using the Clinical Parameters in Patients with Heart Failure
Scientific Title:Acronym Mathematical Prediction of Prognosis for Patients with Heart Failure (PPP study)
Region
Japan

Condition
Condition acute decompensated heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the clinical settings, prognoses for patients with certain diseases are estimated from the results of large-scale trials. To investigate the potential factors for the estimation of prognosis, we formulated the equation to estimate the day of its rehospitalization owing to heart failure and we determined the function f to mathematically formulate the relationship between clinical characteristics and outcomes for these patients. We verify this equation prospectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the time for the first rehospitalization for decompensated heart failure obtained by the equation and clincial practice
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 Hospitalization for occurrence of the acute decompensated heart failure
Key exclusion criteria The patients whose labratory examinations are sufficient.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Kitakaze
Organization National Cerebral and Cardiovascular Center
Division name Department of Clinical Medicine and Development
Zip code
Address 5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN
TEL 06-6833-5012
Email kitakaze@zf6.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Kitakaze
Organization National Cerebral and Cardiovascular Center
Division name Department of Clinical Medicine and Development
Zip code
Address 5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN
TEL 06-6833-5012
Homepage URL http://www.research-assistance.net/HFPR/
Email kitakaze@zf6.so-net.ne.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 08 Month 17 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
waiting for the 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 No longer recruiting
Date of protocol fixation
2012 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
2015 Year 10 Month 01 Day
Date of closure to data entry
2015 Year 10 Month 01 Day
Date trial data considered complete
2016 Year 01 Month 01 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information We enroll all of the patients who matches the entry criteria in each hospital.
age
sex
family living together


the cause of HF
CVD
DCM
HHD
IHD
valve

comorbidity
HT
dyslipidemia
Af
Cerebral VD
COPD

NYHA
HR
edema

CRT
ICD
pacemaker

at admission
blood albumin
CRP

at admission
LVDs
FS

At discharge
WBC
AST
BUN
UA

CRP
BNP

FS
wall thickness
MR
AR
TR

ARB
anti-inflammation
bronchodilator
anti-allergy
anti-platelet
drugs for psychogenic disease
beta blocker
digitalis
diuretics
drugs for constipation
drugs for thyroid gland
drugs for gall stone
drugs for dyslipidemia
drugs for intestine
inotropic agent
PPI
vitamin drugs

Management information
Registered date
2015 Year 08 Month 17 Day
Last modified on
2016 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021637

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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