UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027228 |
|---|---|
| Receipt number | R000023626 |
| Scientific Title | The usefulness of anticholinergic drug to chronic heart failure patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2017/05/10 |
| Last modified on | 2019/05/07 09:27:51 |
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Basic information
Public title
The usefulness of anticholinergic drug to chronic heart failure patients with chronic obstructive pulmonary disease
Acronym
Anticholinergic drug for CHF with COPD
Scientific Title
The usefulness of anticholinergic drug to chronic heart failure patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Anticholinergic drug for CHF with COPD
Region
| Japan |
Condition
Condition
Chronic heart failure with chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the usefulness and impact of anti-oxidative stress effect and prognostic improvement of anticholinergic drug to improve airflow onstruction in chronic heart failure patients with chronic obstructive pulmonary disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac death and rehospitalization due to worsening heart failure
Key secondary outcomes
Index of respiratory function test(FVC, FEV1, FEV1%)
Questionnaires (CAT, mMRC questionnaire)
Laboratory test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tiotropium:150
Period:2014.6-2018.3
Interventions/Control_2
No treatment:150
Period:2014.6-2018.3
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Chronic heart failure with chronic obstructive pulmonary disease
2.Stable outpatients(NYHA I-III)
Key exclusion criteria
1.severe chronic obstructive pulmonary disease
2.acute heart failure patients or acute myocardial infarction patients
3.History and concurrent medical conditions
Having bronchial asthma
Having pulmonary fibrosis definitely
4.Patients who had already drugs for COPD
5.Patents with hypersensitivity of study drug
6.Women who are pregnant, lactating
7.Patients who have been judged ineligible for the study by the investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuchika Takeishi |
Organization
Fukushima Medical University
Division name
Department of Cardiology and Hematology
Zip code
Address
Hikarigaoka 1,Fukushima
TEL
024-547-1111
takeishii@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kobayashi |
Organization
Fukushima Medical University
Division name
Department of Cardiology and Hematology
Zip code
Address
Hikarigaoka 1,Fukushima
TEL
024-547-1111
Homepage URL
koba-a@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Department of Cardiology and Hematology
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Department of Cardiology and Hematology
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
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 | 10 | 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
February 8, 2019 Research discontinued
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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023626
