UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004048
Receipt No. R000004881
Scientific Title Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Date of disclosure of the study information 2010/09/01
Last modified on 2010/08/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Acronym Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Scientific Title Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Scientific Title:Acronym Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Region
Japan

Condition
Condition acute heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of long-term administration of human atrial natriuretic peptide for cardiac function, renal function and rehospitalization rate in patients with acute heart failure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Improvements of left ventricular ejection fraction, concentration of serum creatinine, estimated GFR and BUN at discharge and 6months after discharge
2) Improvements of rehospitalization rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 five days administration of human atrial natriuretic peptide
Interventions/Control_2 more than ten days administration of human atrial natriuretic peptide
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Inpatients with acute congestive heart failure
Key exclusion criteria 1) Patients with a history of hypersensitivity to carperitide
2) Patients with severe hypotention or cardioganic shock
3) Patients with dominant rightventricular heart failure
4) Patients with dehydration
5) Patients with systolic blood pressure <100mmHg
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Yoshiyama
Organization Osaka city university graduate school of medicine
Division name Department of cardiology
Zip code
Address 1-4-3, Asahimachi Abenoku, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihisa Hanatani
Organization Osaka city university graduate school of medicine
Division name Department of cardiology
Zip code
Address
TEL 06-6645-3801
Homepage URL
Email

Sponsor
Institute Department of cardiology
Osaka city university graduate school of medicine
Institute
Department

Funding Source
Organization Department of cardiology
Osaka city university graduate school of medicine
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
2010 Year 09 Month 01 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
2010 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 16 Day
Last modified on
2010 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004881

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.