UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007109 |
|---|---|
| Receipt number | R000008373 |
| Scientific Title | Answering question on tolvaptan's efficacy for patients with acute decompensated heart failure and renal failure: AQUAMARINE Study |
| Date of disclosure of the study information | 2012/01/23 |
| Last modified on | 2015/02/11 18:55:54 |
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Basic information
Public title
Answering question on tolvaptan's efficacy for patients with acute decompensated heart failure and renal failure: AQUAMARINE Study
Acronym
AQUAMARINE
Scientific Title
Answering question on tolvaptan's efficacy for patients with acute decompensated heart failure and renal failure: AQUAMARINE Study
Scientific Title:Acronym
AQUAMARINE
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of tolvaptan on acute congestive heart failure patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
A cumulative urine volume (for 48 hours)
Key secondary outcomes
AKI, Cumulative Urine Volume (1-12 hours),additional diuretics dose, serum BUN, serum Cr, eGFR, BNP, serum Na, serum K, NYHA classification,
Dyspnea (rational symptom), Improvement in signs of heart failure, (rales, edema, gallop rhythm) , Duration of hospital stays
Subgroup analysis: Gender, LVEF >=50%, eGFR<60, eGFR<30, BUN>median value, BUN/Cr>median value, SBP>140, SBP<100, Age >=75 years, prescribed furosemide more than 20mg, ischemic etiology, atrial fibrillation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan Group : Tolvaptan 15mg orally + Furosemide i.v at least 20mg longer that 2 days
Interventions/Control_2
Furosemide i.v at least 20mg longer that 2 days
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
| Not applicable |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with fluid retention in congestive heart failure
(2) Patients who were hospitalized for acute exacerbation of chronic heart failure
(3) glomerular fi ltration rate [eGFR] of 15–60 mL/min/1•73 m²,
(4) Aged 85 years or younger
Key exclusion criteria
(1) Patients with circulatory assist device
(2) Patients with consciousness disturbance
(3) Hypernatremia (serum Na>147mEq/L) (4) Patients with dehydration
(5) Insensitivity to the thirst or difficult for the water intake
(6) Severe hypotension or cardiogenic shock
(7) Patients are considered undesirable rapid decrease in blood flow circulation
(8) Patietns with hypersensitivity to study drug
(9) Anuric patients
(10) Pregnant woman, lactational woman, patients may be willing to be pregnant or are pregnant
(11) In addition, patients were judged as inadequate by physician
(12) Acute myocardial infarction
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Kameda Medical Center
Division name
Department of Cardiology
Zip code
Address
929 Higash-cho, Kamogawa City, Chiba
TEL
(047)-092-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuya Matsue |
Organization
Kameda Medical Center
Division name
Department of Cardiology
Zip code
Address
929 Higash-cho, Kamogawa City, Chiba
TEL
(047)-092-2211
Homepage URL
yuya8950@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Hiroo Hospital, Oume Municipal General Hospital, Social Insurance Chuo General Hospital, Toho-University Ohashi Hospital, Saitama Medical Center, etc.
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 | 01 | Month | 23 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/24048511
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 20 | Day |
Last modified on
| 2015 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008373
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