UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013727 |
|---|---|
| Receipt number | R000016028 |
| Scientific Title | Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction |
| Date of disclosure of the study information | 2014/04/16 |
| Last modified on | 2018/04/19 09:22:16 |
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Basic information
Public title
Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Acronym
Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Scientific Title
Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Scientific Title:Acronym
Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction
Region
| Japan |
Condition
Condition
acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction using cardiac sympathetic nerve activity as an indicator
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
H/M MIBG uptake ratio on the delayed images,
Changes in washout rate of cardiac MIBG
Key secondary outcomes
1)blood biomarkers: vasopressin, three fractions of catecholamine, renin activity, aldosterone levels and serum osmolality
2)urinary biomarker: urinary albumin, urine beta2-microglobulin, urinary L-FABP and urine osmolality
3) Transthoracic echocardiography: LVEF, LVDd/Ds, E/e', LAD
4) Holter electrocardiogram: (TWA, HRV, HRT)
5) arrhythmia
6) cardiovascular event
7) acute kidney injury
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Conventional therapy group
Interventions/Control_2
Tolvaptan add-on therapy group
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with left ventricular ejection fraction>=45%
2) Patients with at least one sign of congestion (edema, pulmonary congestion, pleural effusion, jugular venous distention, orthopnea)
3)Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria
1) Patients with hypernatremia (Na>147mEq/L)
2) Patients who do not need diuretic therapy because of dehydration
3) Patients with cardiovascular shock
4) Patients with anuria or patients under hemodialysis
5) Patients with acute coronary syndrome
6) Patients with insensitivity to thirst or difficulty in water intake
7) Patients who need mechanical circulatory assist device (IABP･PCPS)
8) Patients with malignant tumor
9) Patients who need temporary pacing because of bradycardia
10) Patients who were judged inappropriate by the principal investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Tamaki |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
kenkyusien@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Tamaki |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 04 | Month | 16 | 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
| 2014 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2018 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016028
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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