UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001763 |
|---|---|
| Receipt number | R000001958 |
| Scientific Title | Randomised open-label compatrison study between carperitide and non-carperitide therapy for acute decompensated heart failure |
| Date of disclosure of the study information | 2009/03/10 |
| Last modified on | 2009/03/10 18:22:25 |
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Basic information
Public title
Randomised open-label compatrison study between carperitide and non-carperitide therapy for acute decompensated heart failure
Acronym
Human Atrial natriuretic peptide for prevention of Nephrotoxicity in Patients with acute decompensated heart failure
Scientific Title
Randomised open-label compatrison study between carperitide and non-carperitide therapy for acute decompensated heart failure
Scientific Title:Acronym
Human Atrial natriuretic peptide for prevention of Nephrotoxicity in Patients with acute decompensated heart failure
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of carperitide for renal function in acute decompensated heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of cchangingthe concentration of serum creatinine, estimated GFR and BUN within 7 days after administration of intravenous heart failure agents (carperitide or niterates)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
more than two days administration of carperitide
Interventions/Control_2
more than two days administration of intra-venous heart failure treatment drug
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) Systolic BP >=100mmHg
2) Pulmonary congestion
3) Symptom with dyspnea
4) 15 ml/min/1.73m2=<eGFR<60 ml/min/1.73m2
5) Age over 20years
6) Within 12 hours of admission
7) Informed consent obtained
Key exclusion criteria
1) eGFR<15ml/min/1.73m or hemodialysis
2) Severe hypotention or cardioganic shock
3) Patients with dehydration
4) Dominant rightventricular heart failure
5) Intubated patients
6) Acute myocardial infarction
7) Patients with cancer
8) Patients with pregnancy
9) Prior enrollment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Iwabuchi |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
1-1 Kifunemachi Kokurakita-ward Kitakyushu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Shirai |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
TEL
Homepage URL
kmhptca@kokura-heart.com
Sponsor or person
Institute
Kokura Memorial Hospital department of cardiology
Institute
Department
Personal name
Funding Source
Organization
Kokura Memorial Hospital department of cardiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 03 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2008 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 10 | Day |
Last modified on
| 2009 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001958
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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