UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032295 |
|---|---|
| Receipt number | 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 21:01:23 |
* 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
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
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
takahama@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
