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Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction

Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction - Efficacy of Tolvaptan in acute heart failure patients with preserved left ventricular ejection fraction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013727
Enrollment
120
Registered
2014-04-16
Start date
2014-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute decompensated heart failure

Interventions

Sponsors

Osaka General Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with left ventricular ejection fraction>=45% 2) Patients with at least one sign of congestion (edema, pulmonary congestion, pleural effusion, jugular venous distention, orthopnea) 3)Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study

Exclusion criteria

Exclusion criteria: 1) Patients with hypernatremia (Na>147mEq/L) 2) Patients who do not need diuretic therapy because of dehydration 3) Patients with cardiovascular shock 4) Patients with anuria or patients under hemodialysis 5) Patients with acute coronary syndrome 6) Patients with insensitivity to thirst or difficulty in water intake 7) Patients who need mechanical circulatory assist device (IABP?PCPS) 8) Patients with malignant tumor 9) Patients who need temporary pacing because of bradycardia 10) Patients who were judged inappropriate by the principal investigator

Design outcomes

Primary

MeasureTime frame
H/M MIBG uptake ratio on the delayed images, Changes in washout rate of cardiac MIBG

Secondary

MeasureTime frame
1)blood biomarkers: vasopressin, three fractions of catecholamine, renin activity, aldosterone levels and serum osmolality 2)urinary biomarker: urinary albumin, urine beta2-microglobulin, urinary L-FABP and urine osmolality 3) Transthoracic echocardiography: LVEF, LVDd/Ds, E/e', LAD 4) Holter electrocardiogram: (TWA, HRV, HRT) 5) arrhythmia 6) cardiovascular event 7) acute kidney injury

Countries

Japan

Contacts

Public ContactShunsuke Tamaki

Osaka General Medical Center Department of Cardiology

kenkyusien@gh.opho.jp06-6692-1201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026