UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029375 |
|---|---|
| Receipt number | 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 10:53:17 |
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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
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
anomura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033570
