The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement
NCT ID: NCT02644616
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2014-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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trial group(tolvaptan group)
trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)
tolvaptan+torasemide
tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
control group
control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)
placebo+torasemide
placebo 15mg/d po(10 days) +torasemide 20mg/d iv
Interventions
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tolvaptan+torasemide
tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
placebo+torasemide
placebo 15mg/d po(10 days) +torasemide 20mg/d iv
Eligibility Criteria
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Inclusion Criteria
2. Patients who takes existing diuretic
3. The patient is willing to participate in the study
Exclusion Criteria
2. Anuric patients
3. Patients with hypernatremia
4. Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant
5. Malignant tumor
6. Patients with serious hepatic disorder or Serious Renal failure
7. Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Yuan Fang
Principal Investigator
Principal Investigators
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Fang Yuan
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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FangYuan
Shanghai, Shanghai Municipality, China
Countries
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References
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Yuan F, Wu Z, Jiang L, Zhou J, Xu L, Liu H, Ma L, Zhai Z, Zhang J. Short-Term Effects of Tolvaptan in Tricuspid Insufficiency Combined with Left Heart Valve Replacement-Caused Volume-Overload Patients: Results of a Prospective Pilot Study. Am J Cardiovasc Drugs. 2019 Apr;19(2):211-218. doi: 10.1007/s40256-018-0304-1.
Other Identifiers
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156-ZOC-1401
Identifier Type: -
Identifier Source: org_study_id