UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027173
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Gunma Prefectural Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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