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

Tricuspid Regurgitation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644616
• Other study ID #: 156-ZOC-1401
• Status: Completed
• Phase: Phase 4
• First received: December 29, 2015
• Last updated: December 19, 2016
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Right Heart Failure
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Drug:
• tolvaptan+torasemide
tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
• placebo+torasemide
placebo 15mg/d po(10 days) +torasemide 20mg/d iv

Locations

Country	Name	City	State
China	FangYuan	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment		2015.01-2017.12
Secondary	A cumulative urine volume for 72 hours (all subjects)		2015.01-2017.12
Secondary	Echocardiography results VS the baseline results(all subjects)		2015.01-2017.12
Secondary	Change of right heart failure signs(all subjects)		2015.01-2017.12
Secondary	Onset of cardiovascular event (all subjects)		2015.01-2017.12
Secondary	Onset of serious adverse event(all subjects)		2015.01-2017.12
Secondary	other adverse events(all subjects)		2015.01-2017.12