COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02644616
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : December 20, 2016
Information provided by (Responsible Party):
Yuan Fang, Shanghai Chest Hospital

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.

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Right Heart Failure Drug: tolvaptan+torasemide Drug: placebo+torasemide Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tolvaptan

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

Primary Outcome Measures :
  1. 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 Measures :
  1. A cumulative urine volume for 72 hours (all subjects) [ Time Frame: 2015.01-2017.12 ]
  2. Echocardiography results VS the baseline results(all subjects) [ Time Frame: 2015.01-2017.12 ]
  3. Change of right heart failure signs(all subjects) [ Time Frame: 2015.01-2017.12 ]
  4. Onset of cardiovascular event (all subjects) [ Time Frame: 2015.01-2017.12 ]
  5. Onset of serious adverse event(all subjects) [ Time Frame: 2015.01-2017.12 ]
  6. other adverse events(all subjects) [ Time Frame: 2015.01-2017.12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02644616

Layout table for location information
China, Shanghai
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Chest Hospital
Layout table for investigator information
Principal Investigator: Fang Yuan Shanghai Chest Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yuan Fang, Principal Investigator, Shanghai Chest Hospital Identifier: NCT02644616    
Other Study ID Numbers: 156-ZOC-1401
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yuan Fang, Shanghai Chest Hospital:
safety and efficacy
left heart valves replacement
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators