UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000025838
Receipt No. R000029710
Scientific Title Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Date of disclosure of the study information 2017/01/25
Last modified on 2019/08/03

* 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 Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Acronym Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Scientific Title Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Scientific Title:Acronym Assessment of Pancreatic exocrine function of hospitalized patients with heart failure
Region
Japan

Condition
Condition heart failure
Classification by specialty
Hepato-biliary-pancreatic medicine Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the pancreatic exocrine function in patients with heart failure
Basic objectives2 Others
Basic objectives -Others Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pancreatic exocrine function measured using PFD (pancreatic function diagnostic) test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Pancreatic functional diagnosis test
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria hospitalized patients with heart failure
hospitalized patients without heart failure
Key exclusion criteria Patients with end-stage renal disease (eGFR<30 ml/min) including hemodialysis
Patients with acute pancreatitis
Patients with acute hepatitis
Patients with other diseases which may affect pancreatic exocrine function
Patients with the medicine which may affect pancreatic exocrine function
Pregnancy and patients who is possible to be pregnant
Patients who did not consent
Patients who are considered as inappropriate based on the principle investigators judgement
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takatoshi
Middle name
Last name Kasai
Organization Juntendo University Hospital
Division name Department of Cardiovasacular Medicine
Zip code 113-8431
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL 03-3813-3111
Email tkasai@juntendo.ac.jp

Public contact
Name of contact person
1st name Takatoshi
Middle name
Last name Kasai
Organization Juntendo University Hospital
Division name Department of Cardiovasacular Medicine
Zip code 113-8431
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL 03-3813-3111
Homepage URL
Email tkasai@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization we have no funding source
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Juntendo Hospital Ethics Committee
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan.
Tel 03-5802-1584
Email kenkyu5858@juntendo.ac.jp

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 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Suspended
Date of protocol fixation
2016 Year 12 Month 27 Day
Date of IRB
2017 Year 01 Month 06 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before follow up

Management information
Registered date
2017 Year 01 Month 25 Day
Last modified on
2019 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.