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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.
 
ClinicalTrials.gov Identifier: NCT02644616
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : December 20, 2016
Sponsor:
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

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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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02644616


Locations
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China, Shanghai
FangYuan
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Chest Hospital
Investigators
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Principal Investigator: Fang Yuan Shanghai Chest Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuan Fang, Principal Investigator, Shanghai Chest Hospital
ClinicalTrials.gov 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:
tolvaptan
safety and efficacy
left heart valves replacement
Additional relevant MeSH terms:
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Heart Failure
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Torsemide
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators