UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042852 |
|---|---|
| Receipt number | 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 15:25:59 |
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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
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
kohono@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048915
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
