UMIN-CTR Clinical Trial

Public title

The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients

Acronym

The VSSPS (Vasodilation vs Sympatholytic antihypertensives on Sleep blood Pressure in hypertensive patients with Sleep apnea syndrome) study.

Scientific Title

The effect of bedtime dosing of antihypertensive drug with both alfa and beta sympatholytic action in high-risk obstructive sleep apnea hypertensive patients

Scientific Title:Acronym

The VSSPS (Vasodilation vs Sympatholytic antihypertensives on Sleep blood Pressure in hypertensive patients with Sleep apnea syndrome) study.

Region

Japan

Condition

hypertension with obstructive sleep apnea syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The patients with obstructive sleep apnea syndrome (OSAS) occurs micro-arousal induced apnea during sleep, which lead to sympathetic nervous activation. The blood pressure (BP) surge during sleep in the patients with OSAS might be caused by sympathetic nervous activation. The aim of this study is to compare the effect of carvedilol that have the inhibition of both alfa and beta sympatholytic action with nifedipine on BP surge during sleep in the patients with OSAS.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

The difference in the inhibition of BP surge during sleep between two groups.

Key secondary outcomes

Maximum, minimum and average BP during sleep, morning BP, AHI

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Carvedilol 10-20mg one time dose, followed by Nifedipine 20-40mg one time dose after the 2weeks washout period.

Interventions/Control_2

Nifedipine 20-40mg one time dose, followed by Carvedilol 10-20mg one time dose after the 2weeks washout period.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Hypertensive subjects with OSAS (AHI>15/hr) 1) who were diagnosed previously by the polysomnography, 2) who were unwilling to receive continuous positive airway pressure (CPAP), and whose sleep BP (measured by ABPM) >120/70 mmHg, were recruited.

Key exclusion criteria

Exclusion criteria as follows
1) The patients treated with anti-sympathetic nervous activation agents
2) The patients with bedtime dosing of antihypertensive drug
3) The patients with congestive heart failure (more than NYHA II)
4) The patients with malignancy
5) The patients with renal failure (serum creatinine >2.0 mg/dL) or performing hemodialysis or severe liver dysfunction
6) The patients with contraindication of these drugs
7) The patients with past history of serious side effects
8) The patients who is not given informed consent by themselves
9) The patients decided inappropriate subjects for this study by physicians

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Kazuomi Kario

Organization

Jichi Medical University School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Medicine

Zip code

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN

TEL

+81-285-58-7538

Email

Name of contact person

1st name
Middle name
Last name

Organization

Jichi Medical University School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Medicine

Zip code

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN

TEL

Homepage URL

Email

Institute

Jichi Medical University School of Medicine

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

鷲谷病院　Washiya hospital

Date of disclosure of the study information

2013

Year

04

Month

26

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

Completed

Date of protocol fixation

2009

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

06

Month

01

Day

Last follow-up date

2013

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

26

Day

Last modified on

2013

Year

04

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012391