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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004497
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004888

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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