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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000028039 |
Receipt No. | R000032102 |
Scientific Title | Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure. |
Date of disclosure of the study information | 2017/07/03 |
Last modified on | 2018/09/25 |
Basic information | ||
Public title | Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure. | |
Acronym | Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure. | |
Scientific Title | Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure. | |
Scientific Title:Acronym | Comparison of Tolvaptan treatment and conventional treatment in elderly acute heart failure. | |
Region |
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Condition | |||
Condition | Acute decompensated heart failure | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Changes in circulating plasma volume during Tolvaptan combined use in Acute decompensated heart failure in the elderly. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Changes in circulating plasma volume by IVC. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Acute decompensated heart failure patients diagnosed by Framingham criteria.
2.Patients who are able to take oral medications 3.age 76 over 4.Partients hospitalized for over time visits |
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Key exclusion criteria | 1.Under 75
2.Hypersensitivity for Tolvaptan or Mozavaptan. 3.Anuria 4.Insensitivity to thurst of difficulty in water in take. 5.Patients who already have tolvaptan at entry. 6.Severe coronary arterydisease and cerebrovascular disease. 7.Severe renal failure 8.Hypernatremia(serum Na>146mEq/L)and(serum Na<125mEq/L). 9.Hyperkalemia(serum K>5.5mEq/L)and(serum K<3.0mEq/L). 10.Chronic hepatitis Liver dysfunction(pharmacological etc.). 11.Hepatic encephalopathy. 12.Any conditions inappropriate to this trial deemed by the investigator. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shinshu University Hospital | ||||||
Division name | Second Department of Internalmedicine | ||||||
Zip code | |||||||
Address | 3-1-1,Asahi,Matsumoto.Nagano.Japan | ||||||
TEL | 0263-37-2634 | ||||||
asha_trial@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Iiyama redcross hospital | ||||||
Division name | Division of pharmacy | ||||||
Zip code | |||||||
Address | Iiyama226-1,Iiyama.Nagano.Japan | ||||||
TEL | 0269-62-4195 | ||||||
Homepage URL | |||||||
asha_trial@yahoo.co.jp |
Sponsor | |
Institute | Iiyama redcross hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | None |
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 |
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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 | Terminated | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032102 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |