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

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 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


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

Value
https://center6.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