UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018691 |
|---|---|
| Receipt number | 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 | 2022/02/19 11:00:11 |
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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 | Masafumi |
| Middle name | |
| Last name | Kitakaze |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Clinical Medicine and Development
Zip code
565-8565
Address
5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN
TEL
06-6833-5012
kitakaze@zf6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Masafum |
| Middle name | |
| Last name | i Kitakaze |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Clinical Medicine and Development
Zip code
565-8565
Address
5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN
TEL
06-6833-5012
Homepage URL
http://www.research-assistance.net/HFPR/
kitakaze@zf6.so-net.ne.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
National Cerebral and Cardiovascular Center
Address
5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN
Tel
06-6833-5012
kitakaze@zf6.so-net.ne.jp
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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838101/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29507373/
Number of participants that the trial has enrolled
213
Results
we created a mathematical formula f(x) that precisely predicted the occurrence probability of future cardiovascular outcomes of HF patients per day
Results date posted
| 2022 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
heart failure
Participant flow
we prospectively examined the predictability of f(x) in other 213 patients using 50 clinical parameters in 3 hospitals
Adverse events
heart failure cardiovascular death
Outcome measures
time to the onset of heart failure or cardiovascular death
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 01 | Day |
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
| 2022 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021637
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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