Unique ID issued by UMIN | UMIN000007943 |
---|---|
Receipt number | R000009357 |
Scientific Title | TOLvaptan Effects on RenAl FuNCtion in Heart FailurE |
Date of disclosure of the study information | 2012/05/14 |
Last modified on | 2014/09/09 21:45:08 |
TOLvaptan Effects on RenAl FuNCtion
in Heart FailurE
TOLERANCE
TOLvaptan Effects on RenAl FuNCtion
in Heart FailurE
TOLERANCE
Japan |
congestive heart failure
Cardiology |
Others
NO
To evalute the efficacy and safety of tolvaptan in treating heart failure patients with volume overload despite the use of loop diuretics (Furosemide 20-80mg/day).
Efficacy
Changes in eGFR, Changes in serum sodium
Worsening Renal Function(WRF), leg edema, dyspnea, death due to heart failure and fatal arrhythmia(VT/VF), PRA, PAC, BNP, body weight, echocardiogram
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Central registration
2
Treatment
Medicine |
Tolvaptan group: Add 7.5mg/day administration. If the effect is insufficient, to enable increased up to 15mg/day
Furosemide group: Add furosemide administration
18 | years-old | <= |
85 | years-old | > |
Male and Female
Heart failure patients with volume overload despite the use of loop diuretics (Furosemide 20-80mg/day).
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
60
1st name | |
Middle name | |
Last name | Hisao Ogawa |
Graduate School of Medical Sciences, Kumamoto University
Cardiovascular medicine
Honjyo 1-1-1, Kumamoto
1st name | |
Middle name | |
Last name | Megumi Yamamuro |
Graduate School of Medical Sciences, Kumamoto University
Cardiovascular medicine
Honjyo 1-1-1, Kumamoto
096-373-5175
yamamuro@kumamoto-u.ac.jp
Graduate School of Medical Sciences, Kumamoto University
Clinical Research Foundation
Non profit foundation
Japan
NO
2012 | Year | 05 | Month | 14 | Day |
Unpublished
Completed
2011 | Year | 11 | Month | 29 | Day |
2012 | Year | 02 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2012 | Year | 05 | Month | 14 | Day |
2014 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009357
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |