UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028689 |
|---|---|
| Receipt number | R000032548 |
| Scientific Title | Beneficial Efficacy of Carperitide in Patients with Acute Decompensated Heart Failure |
| Date of disclosure of the study information | 2018/08/29 |
| Last modified on | 2024/05/01 20:12:30 |
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Basic information
Public title
Beneficial Efficacy of Carperitide in Patients with Acute Decompensated Heart Failure
Acronym
BEYOND registry
Scientific Title
Beneficial Efficacy of Carperitide in Patients with Acute Decompensated Heart Failure
Scientific Title:Acronym
BEYOND registry
Region
| Japan |
Condition
Condition
Acute decompensated heart failure (ADHF)
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of carperitide in patients with ADHF, especially focusing on atrial dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total urine volume at 6 hours after an administration of carperitide.
Key secondary outcomes
1.Total urine volume at 12, 24, and 48 hours after an administration of carperitide.
2.Acute kidney injury.
3.Serum Hb, Ht, Cr, BUN, Na, K, Cl, BNP, ANP levels.
4.Urinary findings.
5.Usage and dosage of other diuretic drugs.
6.Symptoms.
7.Congestive physical findings.
8.Duration of hospitalization.
9.Adverse events in hospitalization.
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
1. Acute decompensated heart failure (ADHF) daignosed according to guidelines of American College of Cardiology (ACC)/ American Heart Association (AHA).
2. Patients who are administered carperitide within 6 hours after diagnosis of ADHF.
3. Over 20 years old.
4. Patients who gave consent with registration in this study.
Key exclusion criteria
1. Patients with circulatory assist device
2. Severe hypotension or cardiogenic shock
3. Patients with dehydration
4. Patients with hemodialysis
5. Allergy with carperitide
6. Pregnant women, lactational women, patients may be pregnant or will be pregnant
7. Patitents with acute coronary syndrome
8. Patients who were judged as inappropriate to be enrolled by physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Ikari |
Organization
Tokai University School of Medicine
Division name
Department of Cardiology
Zip code
259-1193
Address
Kanagawaken, Isheharashi, Shimokasuya 143
TEL
0463-93-1121
ikari@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Matsumoto |
| Middle name | |
| Last name | Matsumoto |
Organization
Toho University Faculty of Medicine
Division name
Department of Cardiology
Zip code
143-8541
Address
Kanagawaken, Isheharashi, Shimokasuya 143
TEL
0463-93-1121
Homepage URL
shingomatsumoto0606@gmail.com
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Hattori Clinic
Address
2-12-8, Shinzyuku, Sinzyukuku, Tokyo, Japan
Tel
03-5919-2052
tamura-saiko@hattori-crb.com
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
| 2018 | Year | 08 | Month | 29 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the relationships between beneficial efficacy of carperitide and atrial dysfunction by prospective multicenter registry.
Management information
Registered date
| 2017 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032548
