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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029375
Receipt No. R000033570
Scientific Title Impact of Genetic Testing on Low-density Lipoprotein Cholesterol in Patients with Familial Hypercholesterolemia
Date of disclosure of the study information 2017/10/02
Last modified on 2019/05/13

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Basic information
Public title Impact of Genetic Testing on Low-density Lipoprotein Cholesterol in Patients with Familial Hypercholesterolemia
Acronym GenTLe-FH study
Scientific Title Impact of Genetic Testing on Low-density Lipoprotein Cholesterol in Patients with Familial Hypercholesterolemia
Scientific Title:Acronym GenTLe-FH study
Region
Japan

Condition
Condition Familial hypercholesterolemia
Classification by specialty
Cardiology Endocrinology and Metabolism Adult
Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate whether genetic test and counseling in addition to usual patient education is associated with low-density lipoprotein (LDL) cholesterol in patients with familial hypercholesterolemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL cholesterol levels at 24 weeks after randomization.
Key secondary outcomes Blood test results (total cholesterol, triglyceride, HDL-C, LDL-C, FBG, HbA1C, WBC, RBC, Hemoglobin, Hematocrit, Platelet, ALT, AST, gamma GTP, ALP, T-Bil. Cr, BUN. TP, Alb, UA, Na, K, Cl, Ca, P, hsCRP), smoking habit, drug adherence, and patient satisfaction questionnaire (PSQ-18) score at 24 and 48 weeks after randomization between intervention/control and/or genetic test positive / negative groups.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Gene
Interventions/Control_1 In addition to usual familial hypercholesterolemia (FH) patients' education, we perform genetic tests for genes associated with FH (LDLR, PCSK9, APOB, and LDLRAP1), and individual genetic counseling regarding the genetic test result and his/her future cardiovascular risk.
Interventions/Control_2 Usual FH patients' education
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed with familial hypercholesterolemia by criteria from the Japan Atherosclerosis Society.
2) Patients who have never got genetic tests, or have not yet returned genetic results regarding familial hypercholesterolemia.
3) Patients who can provide written informed consent
Key exclusion criteria 1) Liver dysfunction (AST or ALT > 3 times the UNL)
2) Renal dysfunction (Cr 2.0 mg/dL or greater)
3) Immunosuppression
4) Active cancer
5) Previous history of coronary heart disease:
i) Myocardial infarction
ii) History of percutaneous coronary intervention
iii) Coronary stenosis (75% or greater) previously detected by coronary angiography
6) Female with pregnancy or expected
7) Patients whose doctors in charge consider him/her inappropriate to participate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Nomura
Organization Kanazawa University
Division name Innovative Clinical Research Center (iCREK)
Zip code
Address 13-1 Takara-machi Kanazawa Ishikawa
TEL 076-265-2049
Email anomura@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Nomura
Organization Kanazawa University
Division name Innovative Clinical Research Center (iCREK)
Zip code
Address 13-1 Takara-machi Kanazawa Ishikawa
TEL 076-265-2049
Homepage URL http://icrek.w3.kanazawa-u.ac.jp
Email anomura@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization None.
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 10 Month 02 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 Terminated
Date of protocol fixation
2017 Year 09 Month 29 Day
Date of IRB
2017 Year 10 Month 02 Day
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
2020 Year 03 Month 31 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 10 Month 02 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033570

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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