UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050122 |
|---|---|
| Receipt number | R000057100 |
| Scientific Title | A single-center, prospective, randomized, exploratory study to investigate the influence of ARNI (angiotensin receptor neprilysin inhibitor) in patients with hemodialysis and heart failure: SPREAD trial |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/24 20:53:02 |
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Basic information
Public title
A single-center, prospective, randomized, exploratory study to investigate the influence of ARNI (angiotensin receptor neprilysin inhibitor) in patients with hemodialysis and heart failure: SPREAD trial
Acronym
Exploratory study to investigate the influence of ARNI in patients with hemodialysis and heart failure
Scientific Title
A single-center, prospective, randomized, exploratory study to investigate the influence of ARNI (angiotensin receptor neprilysin inhibitor) in patients with hemodialysis and heart failure: SPREAD trial
Scientific Title:Acronym
Exploratory study to investigate the influence of ARNI in patients with hemodialysis and heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the prognostic influence and safety of sacubitril-valsartan in patients with hemodialysis and heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoint (all cause death and hospitalizations for heart failure, ischemic heart disease, and stroke)
Key secondary outcomes
1) BNP, ANP, NT-proBNP value at 1 month and 1 year.
2) Echocardiographic parameters at 1 and 2 years.
3) Adverse events in sacubitril-valsartan group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer sacbitril valsartan.
Interventions/Control_2
No administration of sacubitril-valsartan(Patients taking angiotensin converting enzyme inhibitor or angiotensin receptor blocker before this study should continue these medicine).
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
1)Patients with hemodialysis
2)Patients with heart failure
3)Patients who can give a written informed consent
Key exclusion criteria
1)Patients who had hypotension before or during the last 3-cycle hemodialysis
2)Hyperkalemia
3)Patients with severe liver disease
4)Patients with a history of hospitalization due to ischemic heart disease or stroke within 3 months.
5)Patients under an unstable heart failure condition
6)Patients with a life expectancy less than 1 year
7)Patients with acute phase disease requiring hospitalization
8)Patients with severe valvular disease
9)Patients with severe respiratory disease
10)Pregnant patients
11)Patients who are suspected of drug allergy to sacubitril-valsartan
12)Patients unable to communicate
13)Patients who are judged inappropriate for this study by investigators
Target sample size
374
Research contact person
Name of lead principal investigator
| 1st name | Yamamoto |
| Middle name | |
| Last name | Junki |
Organization
Masuko Memorial Hospital
Division name
Department of cardiology
Zip code
453-8566
Address
35-28 Takehashi-cho, Nakamura-Ku, Nagoya, Aichi, Japan
TEL
+81-52-451-1307
jun_yama@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yamamoto |
| Middle name | |
| Last name | Junki |
Organization
Masuko Memorial Hospital
Division name
Department of cardiology
Zip code
453-8566
Address
35-28 Takehashi-cho, Nakamura-Ku, Nagoya, Aichi, Japan
TEL
+81-52-451-1307
Homepage URL
jun_yama@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Masuko Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Cardiology, Nagoya City University Graduate School of Medical Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethical Review Board of Masuko Memorial Hospital
Address
35-28 Takehashi-cho, Nakamura-Ku, Nagoya, Aichi, Japan
Tel
+81-52-451-1307
tabata@masuko.or.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
| 2023 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057100
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| Registered date | File name |
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