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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037125
Receipt No. R000042305
Scientific Title Multicenter clinical trial of hANP therapy on outpatient for heart failure.
Date of disclosure of the study information 2019/06/20
Last modified on 2020/01/09

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Basic information
Public title Multicenter clinical trial of hANP therapy on outpatient for heart failure.
Acronym Multicenter clinical trial of hANP therapy on outpatient for heart failure.
Scientific Title Multicenter clinical trial of hANP therapy on outpatient for heart failure.
Scientific Title:Acronym Multicenter clinical trial of hANP therapy on outpatient for heart failure.
Region
Japan

Condition
Condition chronic heart failure(NYHA II to III)
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and problems of carperitide (hANP) therapy for outpatients with chronic heart failure (NYHA II to III ).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hospitalization
Key secondary outcomes BNP or NT-ProBNP
BUN, Cr, eGFR, AST, ALT, urinary albumin
CTR on chest XP, pleural effusion
Echocardiography (LVDd, LVDs, EF,% FS, E / e ', LAD)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 hANP is administered at 0.02 to 0.1 ng/ kg /min as an outpatient for 3 to 5 hours.
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
100 years-old >
Gender Male and Female
Key inclusion criteria Chronic heart failure (NYHA II to III)
Patients from whom informed consent was obtained
Key exclusion criteria Patients from whom informed consent was not obtained
Hemodialysis
Cardiogenic Shock
Heart failure (NYHA IV)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Sezai
Organization Nihon University school of medicine
Division name Department of Cardiovascular Surgery
Zip code 1738610
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email asezai.med@gmail.com

Public contact
Name of contact person
1st name Nozomi
Middle name
Last name Komoda
Organization Nihon University Itabashi Hospital
Division name Clinical research center
Zip code 1738610
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email komoda.nozomi@nihon-u.ac.jp

Sponsor
Institute Nihon University Itabashi Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sekino Hospital
Nihon University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical research center, Nihon University Itabashi Hospital
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
Tel 03-3972-8111
Email komoda.nozomi@nihon-u.ac.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 日大板橋病院(東京都)、関野病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2019 Year 04 Month 05 Day
Anticipated trial start date
2019 Year 04 Month 06 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 20 Day
Last modified on
2020 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042305

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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