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The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement

Primary Purpose

Tricuspid Regurgitation, Right Heart Failure

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tolvaptan+torasemide
placebo+torasemide
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring tolvaptan, safety and efficacy, left heart valves replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient with tricuspid regurgitation and right heart failure after left heart valves replacement
  2. Patients who takes existing diuretic
  3. The patient is willing to participate in the study

Exclusion Criteria:

  1. Patients with hypersensitivity to study drug
  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

Sites / Locations

  • FangYuan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

trial group(tolvaptan group)

control group

Arm Description

trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)

control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)

Outcomes

Primary Outcome Measures

The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment

Secondary Outcome Measures

A cumulative urine volume for 72 hours (all subjects)
Echocardiography results VS the baseline results(all subjects)
Change of right heart failure signs(all subjects)
Onset of cardiovascular event (all subjects)
Onset of serious adverse event(all subjects)
other adverse events(all subjects)

Full Information

First Posted
December 29, 2015
Last Updated
December 19, 2016
Sponsor
Shanghai Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02644616
Brief Title
The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves replacement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation, Right Heart Failure
Keywords
tolvaptan, safety and efficacy, left heart valves replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trial group(tolvaptan group)
Arm Type
Active Comparator
Arm Description
trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)
Intervention Type
Drug
Intervention Name(s)
tolvaptan+torasemide
Intervention Description
tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
Intervention Type
Drug
Intervention Name(s)
placebo+torasemide
Intervention Description
placebo 15mg/d po(10 days) +torasemide 20mg/d iv
Primary Outcome Measure Information:
Title
The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment
Time Frame
2015.01-2017.12
Secondary Outcome Measure Information:
Title
A cumulative urine volume for 72 hours (all subjects)
Time Frame
2015.01-2017.12
Title
Echocardiography results VS the baseline results(all subjects)
Time Frame
2015.01-2017.12
Title
Change of right heart failure signs(all subjects)
Time Frame
2015.01-2017.12
Title
Onset of cardiovascular event (all subjects)
Time Frame
2015.01-2017.12
Title
Onset of serious adverse event(all subjects)
Time Frame
2015.01-2017.12
Title
other adverse events(all subjects)
Time Frame
2015.01-2017.12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with tricuspid regurgitation and right heart failure after left heart valves replacement Patients who takes existing diuretic The patient is willing to participate in the study Exclusion Criteria: Patients with hypersensitivity to study drug Anuric patients Patients with hypernatremia Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant Malignant tumor Patients with serious hepatic disorder or Serious Renal failure Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Yuan
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
FangYuan
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30255476
Citation
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.
Results Reference
derived

Learn more about this trial

The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement

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