UMIN-CTR Clinical Trial

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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