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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005419
Receipt No. R000006428
Scientific Title Evaluation of Salt Intake for the Prediction of Cardiovascular Events in Japanese High-risk Patients
Date of disclosure of the study information 2011/05/01
Last modified on 2019/10/16

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Basic information
Public title Evaluation of Salt Intake for the Prediction of Cardiovascular Events in Japanese High-risk Patients
Acronym ESPRIT
Scientific Title Evaluation of Salt Intake for the Prediction of Cardiovascular Events in Japanese High-risk Patients
Scientific Title:Acronym ESPRIT
Region
Japan

Condition
Condition Patients with the following cardiovascular risk factors
1. Heart failure or history of heart failure
2. Reduced left ventricular ejection fraction
3. Coronary artery disease
4. Atrial fibrillation
5. Cerebrovascular disease
6. Chronic kidney disease
7. Other atherosclerotic disease
8. BNP >100pg/ml
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate whether salt intake evaluated by spot urine is associated with future cardiovascular events
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Combined cardiovascular events

1. Admission due to worsening or new onset heart failure
2. Acute coronary syndrome
3. Cerebrovascular events
4. Other cardiovascular events
Key secondary outcomes 1. Total death
2. Incidence of each cardiovascular events
3. Disease-specific occurrence of cardiovascular events

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 with the following cardiovascular risk factors
1. Heart failure or history of heart failure
2. Reduced left ventricular ejection fraction
3. Coronary artery disease
4. Atrial fibrillation
5. Cerebrovascular disease
6. Chronic kidney disease
7. Other atherosclerotic disease
8. BNP >100pg/ml
Key exclusion criteria Patients with the following cardiovascular events in 6 months
1. Heart failure
2. Acute coronary syndrome
3. Cerebrovascular events
4. Other cardiovascular events
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Tsuneaki
Middle name
Last name Sadanaga
Organization Seigato Hospital
Division name Director
Zip code 861-5347
Address Funatsu 897, Kawach, Nishi-ku, Kumamoto
TEL 096-276-1151
Email kamefu@rb3.so-net.ne.jp

Public contact
Name of contact person
1st name Tsuneaki
Middle name
Last name Sadanaga
Organization Seigato Hospital
Division name Director
Zip code 861-5347
Address Funatsu 897, Kawach, Nishi-ku, Kumamoto
TEL 096-276-1151
Homepage URL
Email kamefu@rb3.so-net.ne.jp

Sponsor
Institute Tsuneaki Sadanaga
Institute
Department

Funding Source
Organization Tsuneaki Sadanaga
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ueki Hospital
Address Iwano 285-29 Kitaku, Ueki, Kumamoto
Tel 0962732111
Email kamefu@rb3.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 熊本市立植木病院(熊本県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 01 Day

Related information
URL releasing protocol None
Publication of results Published

Result
URL related to results and publications http://doi.org/10.1038/s41440-018-0149-7
Number of participants that the trial has enrolled 520
Results During the median follow-up periods of 5.2 years, there were 105 composite CV events including 60 hospitalizations due to heart failure, 9 acute coronary syndromes, 21 cerebrovascular events, 15 CV deaths, and 26 cases of all-cause mortality. After adjustment for age, gender, and body weight, higher sodium excretion more than or equal to 4.0 g/day was associated with composite CV events but not all cause mortality.
Results date posted
2019 Year 10 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 12 Month 05 Day
Baseline Characteristics The average age of the patients was 73 years with a predominance of the male gender (62%) and 254 (49%) patients were older than 75 years.
Participant flow A total of 520 patients who visited cardiology clinic with various cardiovascular risk profile were included. Sodium intake was estimated by spot urine testing at the time of entry and the measurement was repeated at least every 6 months during follow-up.
Adverse events None
Outcome measures The primary endpoint of this study is composed of 1) hospitalization due to heart failure, 2) acute coronary syndrome, 3) cerebrovascular events, and 4) CV deaths. The secondary endpoint is all-cause mortality.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 04 Month 10 Day
Date of IRB
2011 Year 04 Month 10 Day
Anticipated trial start date
2011 Year 04 Month 10 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information Prospective observational study. Basically all the patients who visit our institution and meet the inclusion criteria will be included.

Management information
Registered date
2011 Year 04 Month 10 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006428

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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