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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032295
Receipt No. R000035666
Scientific Title Selection of Nitrate or Carperitide in acute phase for prevention from Cardiovascular events in patients with acute heart failure.
Date of disclosure of the study information 2018/04/18
Last modified on 2018/04/20

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Basic information
Public title Selection of Nitrate or Carperitide in acute phase for prevention from Cardiovascular events in patients with acute heart failure.
Acronym Selection of Nitrate or Carperitide in acute phase for prevention from Cardiovascular events in patients with acute heart failure.
Scientific Title Selection of Nitrate or Carperitide in acute phase for prevention from Cardiovascular events in patients with acute heart failure.
Scientific Title:Acronym Selection of Nitrate or Carperitide in acute phase for prevention from Cardiovascular events 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 This study was aimed to comapre a frequency of composite clinical outcomes between patients treated with carperitide or nitrate: a singlecenter, randomized, open-label, clinical trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of composite cardiovascular event after the initiation of the treatments
Key secondary outcomes 1) Changes in NYHA (before, 3hours and 2days after the initiation of the treatments)
2) Echocardiographical changes (LVDd, LVDs, LVEF, E/A, VTI) (before and 14 days after the the initiation of the treatments)
3) Changes in plasma BNP levels (before and 14 days after the the initiation of the treatments)
4) Changes in systolic blood pressure during protocol
5) Changes in estimated GFR during protocol

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 Initial treatments (intravenous administration) is a randomized (1:1) to carperitide and nitrate.
Interventions/Control_2 Nitrate
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) over 20 years
2) NYHA functional class: 2-3
3) Systolic blood pressure: greater than or equal to 120mmHg
4) written informed consent
Key exclusion criteria 1) Patients with acute myocaridal infarction and unstable angina, which occurs within 3 months
2) Patients with valvular heart disease which requires surgical treatments
3) Patients with persistent fever greater than or equal to 38 degree celcius
4) Patients with cancer
5) Patients who received surgery or significant trauma within 6 months
6) Patients with inflamative disease
7) Patients who requires ventricular assist device
8) Patients who receive dialysis
9) Patients with severe dehydration
10) Patients considered ineligible to participate in this study by physician
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Takahama
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address Fujishirodai, 5-7-1, Suita
TEL 06-6833-5012
Email takahama@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takahama
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address Fujishirodai, 5-7-1, Suita
TEL 06-6833-5012
Homepage URL
Email takahama@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Other
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
2018 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 08 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
2014 Year 09 Month 30 Day
Date trial data considered complete
2014 Year 09 Month 30 Day
Date analysis concluded
2014 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 17 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035666

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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