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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009170
Receipt No. 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

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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
Email

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
Email s-kasama@bay.wind.ne.jp

Sponsor
Institute Kitakanto Cardiovascular Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010760

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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