NCT02408172

Brief Summary

Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to 7% in middle aged individuals and increases with age. OSA has been identified as the most common secondary cause associated with resistant hypertension. There is evidence that compared with older patients, the risk of hypertension in OSA patients may be particularly pronounced in younger adult ones (less than 50 years). Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. In addition, it has been found that hypoxia condition in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP. However, the selections of antihypertensive drugs remain yet not very clearly for hypertensive patients combined with OSA.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 15, 2017

Status Verified

October 1, 2014

Enrollment Period

3.7 years

First QC Date

March 12, 2015

Last Update Submit

February 13, 2017

Conditions

Sleep Apnea SyndromeHypertension

Keywords

hypertensionSleep apnea syndromeAmlodipinemetoprolol

Outcome Measures

Primary Outcomes (1)

  • 24-hour Ambulatory Blood Pressure Monitoring

    up to 3 years

Secondary Outcomes (2)

  • 24-hour continuous ambulatory electrocardiography

    up to 3 years

  • Ultrasonic echocardiography

    up to 3 years

Study Arms (2)

OSA-amlodipine

EXPERIMENTAL

To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment

Drug: Amlodipine

OSA-metoprolol

EXPERIMENTAL

To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment

Drug: metoprolol

Interventions

AmlodipineDRUG

Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.

OSA-amlodipine
metoprololDRUG

Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.

OSA-metoprolol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men aged between 18 and 75 included years old, and
  • Postmenopausal women who are no more than 75 years older.
  • Patients with essential mild to moderate uncomplicated hypertension (DBP\<110mmHg and SBP\<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification,
  • Without antihypertensive treatment in 2 weeks.

You may not qualify if:

  • History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.
  • History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
  • History of renal impairment.
  • History of Type I diabetes mellitus or Type II diabetes uncontrolled.
  • History of liver impairment.
  • History of alcoholism or drug abuse.
  • Known symptomatic orthostatic hypotension.
  • Contra-indications to treatment with investigate products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Portable polysomnography

Suzhou, Jiangsu, China

RECRUITING

Twenty-four-hour ambulatory BP monitoring

Budapest, Budapest, Hungary

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesHypertension

Interventions

AmlodipineMetoprolol

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Central Study Contacts

Yue Li, PHD

CONTACT

86-451-85555673ly99ly@vip.163.com

Jing Shi, MM

CONTACT

86-451-85555672yidashijing@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

April 3, 2015

Study Start

October 1, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

February 15, 2017

Record last verified: 2014-10

Locations

CN(1)HU(1)