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

December 19, 2016 updated by: Yuan Fang, Shanghai Chest Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • FangYuan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: trial group(tolvaptan group)
trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)
Drug: tolvaptan+torasemide
tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
Placebo Comparator: control group
control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)
Drug: placebo+torasemide
placebo 15mg/d po(10 days) +torasemide 20mg/d iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2015.01-2017.12

Secondary Outcome Measures

Outcome Measure
Time Frame
A cumulative urine volume for 72 hours (all subjects)
Time Frame: 2015.01-2017.12
2015.01-2017.12
Echocardiography results VS the baseline results(all subjects)
Time Frame: 2015.01-2017.12
2015.01-2017.12
Change of right heart failure signs(all subjects)
Time Frame: 2015.01-2017.12
2015.01-2017.12
Onset of cardiovascular event (all subjects)
Time Frame: 2015.01-2017.12
2015.01-2017.12
Onset of serious adverse event(all subjects)
Time Frame: 2015.01-2017.12
2015.01-2017.12
other adverse events(all subjects)
Time Frame: 2015.01-2017.12
2015.01-2017.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Investigators

  • Principal Investigator: Fang Yuan, Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 29, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-ZOC-1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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