Right Heart Failure, Tricuspid Regurgitation
Conditions
Keywords
tolvaptan, safety and efficacy, left heart valves replacement
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.
Interventions
DRUGtolvaptan+torasemide
tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
DRUGplacebo+torasemide
placebo 15mg/d po(10 days) +torasemide 20mg/d iv
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment | 2015.01-2017.12 |
Secondary
| Measure | Time frame |
|---|---|
| Echocardiography results VS the baseline results(all subjects) | 2015.01-2017.12 |
| Change of right heart failure signs(all subjects) | 2015.01-2017.12 |
| A cumulative urine volume for 72 hours (all subjects) | 2015.01-2017.12 |
| Onset of serious adverse event(all subjects) | 2015.01-2017.12 |
| other adverse events(all subjects) | 2015.01-2017.12 |
| Onset of cardiovascular event (all subjects) | 2015.01-2017.12 |
Countries
China
Outcome results
None listed