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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042852
Receipt No. R000048915
Scientific Title Assessment of beneficial effects on sympathetic nerve activity by pemafibrate in hypertriglyceridemic patients with obesity and hypertension
Date of disclosure of the study information 2021/01/05
Last modified on 2020/12/25

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Basic information
Public title Effect of PEmafibRate on Sympathetic nErve fUnction in hypertriglyceridemia patients with obeSity and hypertension
Acronym Perseus study
Scientific Title Assessment of beneficial effects on sympathetic nerve activity by pemafibrate in hypertriglyceridemic patients with obesity and hypertension
Scientific Title:Acronym Perseus study
Region
Japan

Condition
Condition Obesity, Hypertension, Dyslipidemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to observe the effect of pemafibrate on sympathetic nervous activity in patients with hypertriglyceridemia associated with obesity and hypertension.
Basic objectives2 Others
Basic objectives -Others To observe the effect of pemafibrate on sympathetic nervous activity
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Change in LF/HF from baseline at 24 weeks post-treatment
Key secondary outcomes 1. Change in HF and LF from baseline at 24 weeks after initiation of treatment
2. Change from baseline at 24 weeks after the start of study treatment for the following
1) Change in heart rate variability index
2) Frequency of extrasystoles and arrhythmias
3) Body measurements: weight, BMI
4) Carotid artery IMT
5) Abdominal circumference, Catecholamine, General blood collection results

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed with dyslipidemia (TG >150 mg/dL at any time) and scheduled to receive pemafibrate.
2. obese patients
3. Patients with hypertension
4. Patients who have given written consent to participate in the clinical study
Key exclusion criteria 1. Patients with contraindications to the target drug.
2. Patients with chronic atrial fibrillation or pacemaker implantation
Patients with severe impairment of cardiovascular or pulmonary function such as shock, heart failure, myocardial infarction, pulmonary embolism, and other patients prone to hypoxemia.
4. Patients with excessive alcohol intake
5. Patients with severe infections, before and after surgery, or with severe trauma
Patients with malnutrition, starvation, weakness, pituitary insufficiency, or adrenal insufficiency.
7. Other patients who are deemed inappropriate by the attending physician.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Koh
Middle name
Last name Ono
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 6068507
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL 0757513190
Email kohono@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Koh
Middle name Ono
Last name Ono
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 6068507
Address 54 Kawahara-cho Shogoin, Sakyo-ku
TEL 0757513190
Homepage URL
Email kohono@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department

Funding Source
Organization Self-adjustment
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Kyoto

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshidakonoe-cho, Sakyo-ku, Kyoto
Tel 0757534680
Email ethcom@kuhp.kyoto-u.ac.jp

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 京都大学医学部付属病院(京都府)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 05 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 Enrolling by invitation
Date of protocol fixation
2020 Year 10 Month 20 Day
Date of IRB
2020 Year 10 Month 20 Day
Anticipated trial start date
2021 Year 01 Month 06 Day
Last follow-up date
2022 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Registration period for research subjects
One year from the date of ethical review approval.
However, the registration period will be shortened if the expected number of cases is reached early.

Management information
Registered date
2020 Year 12 Month 25 Day
Last modified on
2020 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048915

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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