Heart Failure with Preserved Ejection Fraction (HFPEF)
Conditions
Interventions
Additional tolvaptan therapy
Conventional therapy only
Sponsors
Nagoya University Graduate School of Medicine, Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Heart failure patients diagnosed by Framingham criteria 2) patients with refractory fluid retention in spite of loop-diuretic therapy (>20mg frosemide doses) 3) Preserved ejection fraction (LVEF >45%) 4) patients who had a previous history of in-hospital treatment due to heart failure in the past year 5) In-hospital patients at the entry 6) Informed consent by document was obtained
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in renal function (serum creatinine level, estimated GFR) Change in serum sodium level Change in plasma BNP level | — |
Countries
Japan
Contacts
Public ContactTakahiro Okumura
Nagoya University Graduate School of Medicine Department of Cardiology
Outcome results
None listed