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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027173
Receipt No. 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

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Basic information
Public title A Comparative Study of the Usefulness Between Tolvaptan and Carperitide in Elderly Heart Failure Patients over 75 Years Old
Acronym ATACH 75
Scientific Title A Comparative Study of the Usefulness Between Tolvaptan and Carperitide in Elderly Heart Failure Patients over 75 Years Old
Scientific Title:Acronym ATACH 75
Region
Japan

Condition
Condition Heart Failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To consider whether treatment of elderly heart failure mainly based on oral medicine leads to an earlier start of cardiac rehabilitation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Number of days before starting cardiac rehabilitation (group therapy).
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taisuke Nakade
Organization Gunma Prefectural Cardiovascular Center
Division name Department of Cardiology
Zip code
Address 3-12, Kameizumi, Maebashi, Gunma
TEL 027-269-7455
Email atach.75yo@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Taisuke Nakade
Organization Gunma Prefectural Cardiovascular Center
Division name Department of Cardiology
Zip code
Address 3-12, Kameizumi, Maebashi, Gunma
TEL 027-269-7455
Homepage URL
Email atach.75yo@gmail.com

Sponsor
Institute Gunma Prefectural Cardiovascular Center
Institute
Department

Funding Source
Organization No funding Source
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 27 Day
Last modified on
2017 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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