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

Phase 4

Completed

• Conditions: Tricuspid Regurgitation; Right Heart Failure
• Interventions: Drug: tolvaptan+torasemide; Drug: placebo+torasemide

• Registration Number: NCT02644616
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trial group(tolvaptan group)	tolvaptan+torasemide	trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)
control group	placebo+torasemide	control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)

Primary Outcome Measures

Name	Time	Method
The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment	2015.01-2017.12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

FangYuan; 🇨🇳 Shanghai, Shanghai, China