NCT02022618

Brief Summary

Objectives: To analyze the influence on the presence of target organ damage renal, cardiac and vascular of peripheral and central blood pressure, retinal vessels caliber, oxidative stress and polymorphisms of genes VAV-2-3 in hypertensive subjects. Methodology: A cross- sectional design we will performed . Population: 486 hypertensive patients. Target organ damage will be assessed by tests recommended in 2013 European guidelines of hypertension. Blood pressure office and ambulatory, retinal caliber vassels,oxidative stress and polymorphisms VAL -2-3 will be measurement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
454

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

December 10, 2013

Last Update Submit

September 22, 2016

Conditions

Hypertension

Keywords

HypertensionTarget organ damagepolymorphismHypertensive patients

Outcome Measures

Primary Outcomes (1)

  • Target organ damage cardiovascular

    Target organ damage, cardiac (left ventricular hypertrophy), Vascular (Pulse wave velocity and Carotid intima media tickness), and renal (Glomerular filtration low and Microalbuminury)

    1 year

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population: 486 hypertensive patients (20-80 years) will be assessed with all tests recommended in 2013 European guidelines of hypertension

You may qualify if:

  • Subjects diagnosed of essential hypertension and age between 20-80 years.

You may not qualify if:

  • Participants who do not sign the consent written informed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Alamedilla Health center

Salamanca, Salamanca, 37003, Spain

Location

Related Publications (5)

  • ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013 Oct;31(10):1925-38. doi: 10.1097/HJH.0b013e328364ca4c. No abstract available.

    PMID: 24107724BACKGROUND

  • Lorenz MW, Markus HS, Bots ML, Rosvall M, Sitzer M. Prediction of clinical cardiovascular events with carotid intima-media thickness: a systematic review and meta-analysis. Circulation. 2007 Jan 30;115(4):459-67. doi: 10.1161/CIRCULATIONAHA.106.628875. Epub 2007 Jan 22.

    PMID: 17242284BACKGROUND

  • Garcia-Ortiz L, Recio-Rodriguez JI, Parra-Sanchez J, Gonzalez Elena LJ, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Gomez-Marcos MA; Vaso-risk group. A new tool to assess retinal vessel caliber. Reliability and validity of measures and their relationship with cardiovascular risk. J Hypertens. 2012 Apr;30(4):770-7. doi: 10.1097/HJH.0b013e3283506628.

    PMID: 22306849BACKGROUND

  • Fraser HI, Dendrou CA, Healy B, Rainbow DB, Howlett S, Smink LJ, Gregory S, Steward CA, Todd JA, Peterson LB, Wicker LS. Nonobese diabetic congenic strain analysis of autoimmune diabetes reveals genetic complexity of the Idd18 locus and identifies Vav3 as a candidate gene. J Immunol. 2010 May 1;184(9):5075-84. doi: 10.4049/jimmunol.0903734. Epub 2010 Apr 2.

    PMID: 20363978BACKGROUND

  • Gomez-Marcos MA, Gonzalez-Sarmiento R, Recio-Rodriguez JI, Agudo-Conde C, Gamella-Pozuelo L, Perretta-Tejedor N, Martinez-Salgado C, Garcia-Ortiz L; Members of the LOD-Hipertension Group. Relationship between target organ damage and blood pressure, retinal vessel calibre, oxidative stress and polymorphisms in VAV-2 and VAV-3 genes in patients with hypertension: a case-control study protocol (LOD-Hipertension). BMJ Open. 2014 Apr 3;4(4):e005112. doi: 10.1136/bmjopen-2014-005112.

    PMID: 24699462DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Human biospecimens used will be collected, stored, used, shared, and disposed of in accordance with the informed consent signed by the subject, or under a waiver of informed consent granted by an independent ethical review body, in accordance to Spanish Law (Ley Orgánica de Protección de Datos de Carácter Personal (15/1999 del 13 de Diciembre, LOPD), y en las condiciones que marca la Ley 14/2007 de investigación biomédica) of Protection of Human Subjects.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Manuel A Gomez Marcos, MD

    Fundacion Infosalud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 30, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

ES(1)