UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005419 |
|---|---|
| Receipt number | 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 14:05:28 |
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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
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
kamefu@rb3.so-net.ne.jp
Sponsor or person
Institute
Tsuneaki Sadanaga
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006428
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