JPRN-UMIN000006258Completed未知
Randomized controlled trial of tolvaptan and carperitide to fluid retention in patients with congestive heart failure - Randomized trial of tolvaptan and carperitide on heart failure patients
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Fukushima Medical University
- Enrollment
- 100
Study Overview
Brief Summary
One hundred and nine hospitalized ADHF patients were enrolled and randomly assigned to tolvaptan or carperitide treatment groups. Subjective symptoms and plasma BNP level were similarly improved by treatment in both groups. Urine volume was significantly higher in the tolvaptan group (P<0.05), but volume of water intake was also higher in the tolvaptan group (P<0.05). Blood pressure was significantly lower in the carperitide group than in the tolvaptan group after treatment (P<0.05). Less adverse events such as worsening heart failure and hypotension requiring drug discontinuation were observed in the tolvaptan group (P=0.027). The average drug cost of tolvaptan was lower than that of carperitide (P<0.001).
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1) Patients with circulatory assist device (2) Acute myocardial infarction (3) Patients with dehydration (4) Severe hypotension or cardiogenic shock (5) Patients with right heart ventricular infarction (6) Patients are considered undesirable rapid decrease in blood flow circulation (7) Patietns with hypersensitivity to study drug (8) Anuric patients (9) Insensitivity to the thirst or difficult for the water intake (10) Hypernatremia (serum Na>147mEq/L) (11) Pregnant woman, lactational woman, patients may be willing to be pregnant or are pregnant (12) In addition, patients were judged as inadequate by physician
Investigators
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