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TOLvaptan Effects on RenAl FuNCtion in Heart FailurE

TOLvaptan Effects on RenAl FuNCtion in Heart FailurE - TOLERANCE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007943
Enrollment
60
Registered
2012-05-14
Start date
2012-02-01
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

congestive heart failure

Interventions

Tolvaptan group: Add 7.5mg/day administration. If the effect is insufficient, to enable increased up to 15mg/day Furosemide group: Add furosemide administration

Sponsors

Graduate School of Medical Sciences, Kumamoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Heart failure patients with volume overload despite the use of loop diuretics (Furosemide 20-80mg/day).

Exclusion criteria

Exclusion criteria: 1) Patients with decompensated HF in acute period 2) Patients with cardiac assist device 3) Patients with dehydration 4) Patients with severe hypotention or cardioganic shock 5) Patients with impaired consciousness 6) Patients who cannot feel thirst and are difficult to intake of fluid 7) Patient who is evaluated to be undesirable rapid decrease in circulating plasma volume 8) Patients who a history of hypersensitivity to tolvaptan 9) Patients with anuria, dialysis patient 10) Patients with severe aortic stenosis, mitral stenosis 11) Scheduled patients underwent coronary angioplasty within the study period, and patients with acute coronary syndrome 12) Hypertrophic obstructive cardiomyopathy 13) Patients with hypernatremia(serum Na+ >145 mEq/L) 14) Patients with hyperpotassemia(serum K+ >5.5 mEq/L) 15) Patient is willing to pregnant or potentially pregnant women, nursing mothers, pregnant 16) Patients with cancer 17) Patients considered not eligible for the study by the attending doctor due to other reasons

Design outcomes

Primary

MeasureTime frame
Changes in eGFR, Changes in serum sodium

Secondary

MeasureTime frame
Worsening Renal Function(WRF), leg edema, dyspnea, death due to heart failure and fatal arrhythmia(VT/VF), PRA, PAC, BNP, body weight, echocardiogram

Countries

Japan

Contacts

Public ContactMegumi Yamamuro

Graduate School of Medical Sciences, Kumamoto University Cardiovascular medicine

yamamuro@kumamoto-u.ac.jp096-373-5175

Outcome results

None listed

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