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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Right Heart Failure; Tricuspid Regurgitation

Treatments: Drug: placebo+torasemide; Drug: tolvaptan+torasemide

Study type: Interventional

Funder types: Other

Identifiers

NCT02644616

156-ZOC-1401

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

trial group(tolvaptan group)

Active Comparator group

Description:

trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20)

Treatment:

Drug: tolvaptan+torasemide

control group

Placebo Comparator group

Description:

control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20)

Treatment:

Drug: placebo+torasemide