Unique ID issued by UMIN | UMIN000027173 |
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Receipt number | R000031096 |
Scientific Title | A Comparative Study of the Usefulness Between Tolvaptan and Carperitide in Elderly Heart Failure Patients over 75 Years Old |
Date of disclosure of the study information | 2017/05/01 |
Last modified on | 2017/04/27 23:16:35 |
A Comparative Study of the Usefulness Between Tolvaptan and Carperitide in Elderly Heart Failure Patients over 75 Years Old
ATACH 75
A Comparative Study of the Usefulness Between Tolvaptan and Carperitide in Elderly Heart Failure Patients over 75 Years Old
ATACH 75
Japan |
Heart Failure
Medicine in general | Cardiology |
Others
NO
To consider whether treatment of elderly heart failure mainly based on oral medicine leads to an earlier start of cardiac rehabilitation.
Efficacy
Exploratory
Not applicable
Number of days before starting cardiac rehabilitation (group therapy).
Measurement and amount and percentage change from the baseline of each observation point for the following parameters:
1.Urine volume
2.Exercise tolerance measured during cardiopulmonary exercise testing
3.Body weight
4.Vital signs and general blood/urine tests
5.Special blood/urine tests
6.Incidence of abnormal electrolyte levels(Na and K)
7.The cost of heart failure treatment until the start of cardiac rehabilitation.
8.Number of days until the improvement of SpO2(>97%)
9.Number of patients who need the rescue remedy (Systolic blood pressure<90mmHg or use of cathecholamine with in 48hours)
10.The ratio of continuous outpatient rehabilitation.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Group A: Administer carperitide
Carperitide is administered in addition to oral diuretic being taken at the time of registration to this study, and continued for 48 hours.
Carperitide is initiated at a density of 0.025 microgram/kg/min and not increased until the 48 hour observation point.
Group B: Administer tolvaptan
Tolvaptan is administered in addition to oral diuretic being taken at the time of registration to this study, and continued for 48 hours.
Tolvaptan is initiated at a dose of 7.5mg and not increased until the 48 hour observation point.
75 | years-old | <= |
Not applicable |
Male and Female
Patients who meet all of the following criteria are included in this study.
1.The patients who are hospitalized due to the exacerbation of cardiac heart failure.
2.Patients whose systolic blood pressure on admission is between 100mmHg to 140mmHg.
3.Patients who are at least 75 years old when he or she agreed to this study.
4.Patients, including patient's custody, spouse, guardian or similar subject, who agreed within 6 hours after hospital admission.
Patients who fall into one or more of the following criteria are excluded from participating in the study.
1.Dialysis patients.
2.Patients with no urine production:<100ml/day.
3.Patients who do not feel thirsty or have difficulty to take water orally.
4.Patients who have already used tolvaptan before hospitalized.
5.Patients who have an allergic past history to tolvaptan.
6.Patients who use ASV within 48 hours after registration.
7.Patients who take SGLT2 inhibitors within 48 hours after registration.
8.Patients who are assessed to be inappropriate for the study by study investigators.
30
1st name | |
Middle name | |
Last name | Taisuke Nakade |
Gunma Prefectural Cardiovascular Center
Department of Cardiology
3-12, Kameizumi, Maebashi, Gunma
027-269-7455
atach.75yo@gmail.com
1st name | |
Middle name | |
Last name | Taisuke Nakade |
Gunma Prefectural Cardiovascular Center
Department of Cardiology
3-12, Kameizumi, Maebashi, Gunma
027-269-7455
atach.75yo@gmail.com
Gunma Prefectural Cardiovascular Center
No funding Source
Self funding
NO
2017 | Year | 05 | Month | 01 | Day |
Partially published
Preinitiation
2017 | Year | 04 | Month | 27 | Day |
2017 | Year | 05 | Month | 01 | Day |
2017 | Year | 04 | Month | 27 | Day |
2017 | Year | 04 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031096
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