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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001763
Receipt No. 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

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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
Email

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
Email kmhptca@kokura-heart.com

Sponsor
Institute Kokura Memorial Hospital department of cardiology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001958

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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