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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028689
Receipt No. 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 2018/10/01

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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
Middle name
Last name Yuji Ikari
Organization Tokai University School of Medicine
Division name Department of Cardiology
Zip code
Address Kanagawaken, Isheharashi, Shimokasuya 143
TEL 0463-93-1121
Email ikari@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Matsumoto
Organization Tokai University School of Medicine
Division name Department of Cardiology
Zip code
Address Kanagawaken, Isheharashi, Shimokasuya 143
TEL 0463-93-1121
Homepage URL
Email shingomatsumoto0606@gmail.com

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization none
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
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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 21 Day
Date of IRB
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
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032548

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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