UMIN-CTR Clinical Trial

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

Essential hypertension

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

03

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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