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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027228
Receipt No. 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

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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
Email 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
Email koba-a@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Department of Cardiology and Hematology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023626

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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