UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009170 |
|---|---|
| Receipt number | R000010760 |
| Scientific Title | Evaluation of Cardiac Sympathetic Nerve Activity and Aldosterone Suppression in Patients With Decompensated Acute Heart Failure on the Treatment Containing Intravenous Atrial Natriuretic Peptide |
| Date of disclosure of the study information | 2012/10/23 |
| Last modified on | 2012/10/23 12:42:32 |
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Basic information
Public title
Evaluation of Cardiac Sympathetic Nerve Activity and Aldosterone Suppression in Patients With Decompensated Acute Heart Failure on the Treatment Containing Intravenous Atrial Natriuretic Peptide
Acronym
ANP in Decompensated AHF
Scientific Title
Evaluation of Cardiac Sympathetic Nerve Activity and Aldosterone Suppression in Patients With Decompensated Acute Heart Failure on the Treatment Containing Intravenous Atrial Natriuretic Peptide
Scientific Title:Acronym
ANP in Decompensated AHF
Region
| Japan |
Condition
Condition
decompensated acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigated the effects of intravenous atrial natriuretic peptide (ANP) on cardiac sympathetic nerve activity (CSNA) and aldosterone suppression in patients with decompensated acute heart failure (AHF).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
I-123 MIBG scintigraphic parameters
plasma aldosterone concentrations
Key secondary outcomes
Left ventricular (LV) end-diastolic volume, end-systolic volume, and ejection fraction
plasma BNP concentrations
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
intravenous atrial natriuretic peptide (ANP)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Admitted to our institutions
2) A first episode of decompensated AHF
3) Left ventricular (LV) ejection fraction (EF) of <45%.
Key exclusion criteria
1) Cardiogenic shock or hypotension
2) History of myocardial infarction or coronary artery disease
3) Severe heart failure requiring mechanical support (intraaortic balloon pumping, left ventricular assist device, or cardiac resynchronization therapy)
4) Requiring heart transplantation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Ichikawa |
Organization
Kitakanto Cardiovascular Hospital
Division name
Internal Medicine
Zip code
Address
740 Shimohakoda, Hokkitsu-machi, Shibukawa, Gunma, Japan
TEL
027-232-7111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shu Kasama |
Organization
Kitakanto Cardiovascular Hospital
Division name
Internal Medicine
Zip code
Address
740 Shimohakoda, Hokkitsu-machi, Shibukawa, Gunma, Japan
TEL
027-232-7111
Homepage URL
s-kasama@bay.wind.ne.jp
Sponsor or person
Institute
Kitakanto Cardiovascular Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitakanto Cardiovascular Hospital
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
| 2012 | Year | 10 | Month | 23 | 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
Completed
Date of protocol fixation
| 2004 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 23 | Day |
Last modified on
| 2012 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010760
