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 2021/06/01 13:28:42

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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

Email

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


Email

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

Email

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

Main results already published

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

2021 Year 06 Month 01 Day



Link to view the page

Value
https://center6.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