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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029132
Receipt No. 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 2018/09/14

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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
Middle name
Last name Yasuchika Takeishi
Organization Fukushima Medical University
Division name Cardiovascular Medicine
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1190
Email intmed1@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiomi Yoshihisa
Organization Fukushima Medical University
Division name Cardiovascular Medicine
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1190
Homepage URL
Email yoshihis@fmu.ac.jp

Sponsor
Institute Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan
Institute
Department

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
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
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
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
Anticipated trial start date
2009 Year 07 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 Prospective observational cohort study

Management information
Registered date
2017 Year 09 Month 13 Day
Last modified on
2018 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033309

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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