Efficacy of Tolvaptan in heart failure patients with preserved Ejection fraction: multicenter, RaNdomized, open-label triAL (ETERNAL)
Not Applicable
- Conditions
- Heart Failure with Preserved Ejection Fraction (HFPEF)
- Registration Number
- JPRN-UMIN000011012
- Lead Sponsor
- agoya University Graduate School of Medicine, Department of Cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Hypernatremia (serum Na >145mEq/L) 2) patients who already have tolvaptan at the entry 3) Insensitivity to the thirst or difficult for the water intake 4) Anuria 5) Hepatic disease 6) Pregnant or possibly pregnant 7) A history of hypersensitivity to tolvaptan 8) Severe valvular heart diseases with significant regurgitation and/or stenosis, pulmonary disease 9) Constrictive pericarditis 10) Malignancy 11) Scheduled surgical procedure 12) Any conditions inappropriate to this trial by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in renal function (serum creatinine level, estimated GFR) Change in serum sodium level Change in plasma BNP level
- Secondary Outcome Measures
Name Time Method