UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029132 |
|---|---|
| Receipt number | R000033309 |
| Scientific Title | Prospective cohort study of patients with heart failure and/or heart failure wannabees |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2023/09/20 19:11:53 |
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Basic information
Public title
Prospective cohort study of patients with heart failure and/or heart failure wannabees
Acronym
Heart failure cohort study
Scientific Title
Prospective cohort study of patients with heart failure and/or heart failure wannabees
Scientific Title:Acronym
Heart failure cohort study
Region
| Japan |
Condition
Condition
Heart failure, Cardiovascular disease, Coronary artery disease, Cardiomyopathy, Arrhythmia, Pulmonary hypertension, Sleep apnea syndrome, Hypertension, Diabetes, Dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Nephrology | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the long term prognosis of patients with heart failure and causes of heart failure (e.g, Cardiovascular disease, Coronary artery disease, Cardiomyopathy, Arrhythmia, Pulmonary hypertension, Sleep apnea syndrome, Hypertension, Diabetes, Dyslipidem), and to consider several findings of each examination and comprehensive management of heart failure.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Long term prognosis (all-cause mortality, cardiac death, non-cardiac death, hospitalization from worsening heart failure, cardiovascular event).
Key secondary outcomes
Findings of each examination (laboratory data, XP, ECG, echocardiography, myocardial scintigraphy, imaging study, polysomnography, cardiopulmonary exercise testing).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet Framingham criteria and/or guidelines of heart failure. Patients with causes of heart failure (e.g. cardiovascular disease, coronary artery disease, cardiomyopathy, arrhythmia, pulmonary hypertension, sleep apnea syndrome, diabetes, hypertension, dyslipidemia).
Key exclusion criteria
The patients who do not agree with the enrollment of this study.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Yasuchika |
| Middle name | |
| Last name | Takeishi |
Organization
Fukushima Medical University
Division name
Cardiovascular Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1190
intmed1@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Akiomi |
| Middle name | |
| Last name | Yoshihisa |
Organization
Fukushima Medical University
Division name
Cardiovascular Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1190
Homepage URL
yoshihis@fmu.ac.jp
Sponsor or person
Institute
Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan
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
Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan
Address
1 Hikarigaoka, Fukushima, Japan
Tel
81-24-547-1190
intmed1@fmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
823
Org. issuing International ID_1
Fukushima Medical University
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 | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.fmu.ac.jp/home/int-med1/reserch-c-hf.htm
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
No
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2040 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational cohort study
Management information
Registered date
| 2017 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033309
