UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037125 |
|---|---|
| Receipt number | 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 | 2023/12/23 10:42:26 |
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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
100
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
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
komoda.nozomi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
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
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
93
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
| 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
| 2023 | Year | 12 | Month | 20 | 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
| 2023 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042305
