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Recruitment status Completed
Unique ID issued by UMIN UMIN000015189
Receipt No. R000017605
Scientific Title Research on the Correction Method of Electrocardiographic QT Interval in Relation to Heart Rate: Study on Optimal Conditions for the Adoption of Data with Increased Heart Rate by Exercise
Date of disclosure of the study information 2014/09/17
Last modified on 2014/09/24

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Basic information
Public title Research on the Correction Method of Electrocardiographic QT Interval in Relation to Heart Rate:
Study on Optimal Conditions for the Adoption of Data with Increased Heart Rate by Exercise
Acronym QT-LT
Scientific Title Research on the Correction Method of Electrocardiographic QT Interval in Relation to Heart Rate:
Study on Optimal Conditions for the Adoption of Data with Increased Heart Rate by Exercise
Scientific Title:Acronym QT-LT
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the RR-QT relationship using ECG data in a resting state and during increased heart rates in adult subjects and the appropriate data for TQTs.
Basic objectives2 Others
Basic objectives -Others To examine best method of exercise load
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Coeffient of determination between QT and RR interval
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Tredmill exercise load
Interventions/Control_2 Master double two-step exercise load
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male
Key inclusion criteria 1. Subjects, Japanese male, are between 20 and 40 years old at the time of Informed Consent

2. Subjects must be 17.6-26.4kg/m2 in BMI

3. Subject must be judged eligible for inclusion in the study by the investigator after examining the investigator's interview, a subjective symptom, physical and laboratory test
Key exclusion criteria 1. A person who take some medicine, except local administration, within 7 days before hospitalization
2. A person who have risk factors of Trsade de Pointes, cardiac insufficiency, hypokalemia, QT-prolongation syndrome, etc
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Kumagai
Organization Kitasato University East Hospital
Division name Clinical Trial Center
Zip code
Address 2-1-1, Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan
TEL 042-748-9111
Email kuma-guy@za2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutoshi Sakamoto
Organization Kitasato University
Division name Clinical Research Center
Zip code
Address 1-15-1, Kitasato, Minami, Sagamihara, Kanagawa, 252-0374 Japan
TEL 042-778-9547
Homepage URL
Email kcrcinfo@med.kitasato-u.ac.jp

Sponsor
Institute Clinical Trial Center, Kitasato University East Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kitasato University
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
2014 Year 09 Month 17 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 Completed
Date of protocol fixation
2013 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 03 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
2014 Year 09 Month 17 Day
Last modified on
2014 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017605


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