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Efficacy and safety of tolvaptan in patients with severe aortic stenosis and chronic kidney disease undergoing transcatheter aortic valve replacement

Efficacy and safety of tolvaptan in patients with severe aortic stenosis and chronic kidney disease undergoing transcatheter aortic valve replacement - TOlvaptan in Patients with severe aortic Stenosis undergoing Transcatheter Aortic valve Replacement (TOPSTAR)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033577
Enrollment
40
Registered
2018-07-31
Start date
2018-07-31
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

aortic valve stenosis, chronic kidney disease

Interventions

After qualification, the subjects are assigned 1: 1 ratio to the furosemide continuation group or tolvaptan administration group. Furosemide continuation group will continue the preoperative dose. For

Sponsors

Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who satisfy all the following criteria are targeted. 1 Patient who is visiting or hospitalized for department of cardiovascular surgery or cardiology at Tokyo Women's Medical University Hospital 2 Patients diagnosed as severe aortic valve stenosis and judged to require TAVI treatment 3 Patients with complication of chronic kidney disease witheGFR <45 mL / min / 1.73 m 2 at the time of qualification confirmation 4 Patients who routinely use loop diuretics before TAVI surgery

Exclusion criteria

Exclusion criteria: Patients who violate the following criteria are excluded from this study 1 Patients receiving hemodialysis therapy 2 patients already taking tolvaptan 3 Patients with difficult oral medication 4 Patients who do not feel dry mouth 5 Those whose serum sodium level measured within 24 hours before the start of the study drug exceeds 150 mEq / ml 6 In addition, patients whose research managers judged inappropriate as subjects

Design outcomes

Primary

MeasureTime frame
Changes in renal function before and one month after treatment

Secondary

MeasureTime frame
Changes before and one month after treatment of the following items 1 weight 2 blood pressure 3 urine volume, urine osmotic pressure 4 serum electrolyte 5 Serum osmotic pressure 6 nerve fluid factor 7 Presence or absence of atrial fibrillation 8 echocardiographic findings

Countries

Japan

Contacts

Public ContactSatoru Domoto

Tokyo Women's Medical University Department of Cardiovascular Surgery

domoto.satoru@twmu.ac.jp+81333538111

Outcome results

None listed

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