NCT01113359

Brief Summary

It has been reported that mouse cytomegalovirus infection alone can elevate the blood pressure in mice. Since HCMV has uniquely evolved with its human host, with little genetic similarity to the animal CMV counterparts, and it only replicates in human, an epidemiological study is required to define the relevance of HCMV infection and expression of hcmv-miRNA-UL112 to the pathogenesis of essential hypertension. The investigators found that hcmv-miR-UL112, a human cytomegalovirus (HCMV)-encoded miRNA, was highly expressed in the hypertensive patients. Among the top miRNA target predictions, the investigators demonstrate that IRF-1 is a direct target gene of hcmv-miR-UL112, along with MICB that has been previously reported. Both IRF-1 and MICB play critical roles in immuno/inflammatory and anti-infection response. Thus, the investigators speculated that IRF-1 and MICB repression by hcmv-miR-UL112 could be considered a unifying mechanism that evades the host response at several levels: antiviral, inflammatory, and immune. In addition, there is an increasing evidence that IRF-1 may be important in apoptosis, angiogenesis, neointima formation and the pathogenesis of vascular diseases. IRF-1 can up-regulate angiotensin II type 2 receptor (AGTR2) that exerts antiproliferative and proapoptotic actions and affects regulation of blood pressure. It has been reported that the targeted disruption of the mouse AGTR2 gene resulted in a significant increase in blood pressure and increased sensitivity to angiotensin II. The nitric oxide synthase expression and NO synthesis in macrophages and distinct cardiomyocytes are induced and controlled by IRF-1 in response to inflammation, important steps in vascular biology that may improve endothelial function and inhibit smooth muscle cell migration, and a key pathophysiological event in hypertension. Collectively, these reports support a strong relationship between IRF-1 regulation and hypertension, indicating a potential role of hcmv-miR-UL112 and HCMV infection in the pathogenesis of hypertension.Thus, the investigators want to investigate the potential link between HCMV infection and essential hypertension.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 29, 2010

Status Verified

April 1, 2010

Enrollment Period

1 month

First QC Date

April 27, 2010

Last Update Submit

April 28, 2010

Conditions

Keywords

HCMV infectionHypertensionThe Potential Link Between HCMV Infection and Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • The positive rate of HCMV infection in hypertensive patients and healthy control

    1 month

Secondary Outcomes (1)

  • HCMV copies number per ml plasma of hypertensive patients and healthy controls

    1 month

Study Arms (2)

study group

hypertensive patients

control group

healthy volunteer

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

essential hypertensive patients:

You may qualify if:

  • Patients with essential hypertension are assessed for potential secondary causes, for the severity of hypertension, other risk factors and for end-organ damage
  • Aged between 30 to 60 years
  • Untreated (whole day average \> 140/90 mmHg) or treated hypertension whole-day average \< 140/85), as determined by 24-hour blood pressure monitoring.

You may not qualify if:

  • Cancer
  • Diabetes
  • Smoking
  • Renal failure
  • Stroke
  • Peripheral artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jun Cai

Beijing, Chaoyang, 100020, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Cytomegalovirus InfectionsHypertensionEssential Hypertension

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsVascular DiseasesCardiovascular Diseases

Study Officials

  • Xin-Chun Yang, MD

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 29, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 29, 2010

Record last verified: 2010-04

Locations