UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004497 |
|---|---|
| Receipt number | R000004888 |
| Scientific Title | Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Hypertension |
| Date of disclosure of the study information | 2011/03/10 |
| Last modified on | 2011/04/05 15:38:14 |
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Basic information
Public title
Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Hypertension
Acronym
SEE-THRU BP
Scientific Title
Clinical Significance of Sphingosine-1-Phosphate in the Evaluation of Endothelial Function and Cardiovascular Risk in Hypertension
Scientific Title:Acronym
SEE-THRU BP
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The endothelium is one of the most important targets of cardiovascular risk factors including hypertension, dyslipidemia, and diabetes mellitus. Endothelial dysfunction is not only the initial step of atherosclerosis, leading to systemic vascular damage, but also a novel predictor of cardiovascular events. Sphingosine 1-phosphate (S1P) is a potent bioactive lipid responsible for vascular cell protection in vitro. The present study was designed to investigate (1) relationship of S1P with endothelial function and cardiovascular risk factors and (2) effects of medical treatments on S1P, endothelial function, and their relationship in patients with hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint is the change in the plasma S1P concentration and endothelial function from baseline to 8 weeks after each treatment.
Key secondary outcomes
Secondary endpoints:
(1) The change in lipid profiles (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) from baseline to 8 weeks after each treatment.
(2) The change in fasting plasma glucose, C-reactive protein, serotonin, malondialdehyde-modified low-density lipoproteitn (MDA-LDL) from baseline to 8 weeks after each treatment.
(3) The change in urine albumin excretion from baseline to 8 weeks after each treatment.
(4) The change in brachial-ankle pulse wave velocity from baseline to 8 weeks after each treatment.
(5) The change in the number of progenitor cell (CD34+ cell) from baseline to 8 weeks after each treatment.
(6) The change in the number of endothelial progenitor cells (positive for DiI-acLDLuptake and FITC-lectin binding staining) from baseline to 8 weeks after each treatment.
(7) The change in brachial blood pressure, estimated central aortic pressure, and heart rate from baseline to 8 weeks after each treatment.
(8) The change in expression of microRNA associated with endothelial function from baseline to 8 weeks after each treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SEE-THRU BP is a 16-week, cross-over, prospective, randomized, open, blinded-endpoint (PROBE) study. After a screening phase for eligibility, baseline data are obtained. Then, patients are assigned to receive either telmisartan (40mg, daily; Group 1) or atenolol (50mg, daily; Group 2) for 8 weeks.
Group 1:
Antihypertensive drugs other than telmisartan, if any at baseline, are continued and not changed throughout the study period. After 8 weeks, telmisartan is switched to atenolol (50mg, daily) and patients are treated for another 8 weeks.
Interventions/Control_2
After a screening phase for eligibility, baseline data are obtained. Then, patients are assigned to receive either telmisartan (40mg, daily; Group 1) or atenolol (50mg, daily; Group 2) for 8 weeks.
Group 2:
Antihypertensive drugs other than atenolol, if any at baseline, are continued and not changed throughout the study period. After 8 weeks, atenolol is switched to telmisartan (40mg, daily) and patients are treated for another 8 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with hypertension who have not been treated with antihypertensive drug
Key exclusion criteria
Exclusion criteria are: history of coronary heart disease, heart failure, or stroke; diabetes mellitus; metabolic syndrome; malignant neoplasm; active inflammatory disease; pregnant women
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuaki Dohi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Cardio-Renal medicine and Hypertensiojn
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Cardio-Renal medicine and Hypertensiojn
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
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
| 2011 | Year | 03 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 02 | Day |
Last modified on
| 2011 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004888
