NCT00943774

Brief Summary

Baroreflex sensitivity is integral to blood pressure regulation, and varies among healthy, normotensive individuals. A reduced compensatory ability of baroreflex buffering in patients with carotid denervation results in blood pressure variability and an elevated blood pressure response to mental stress. Furthermore, 24-hour ambulatory blood pressure variability may also be a significant and independent risk determinant of cardiovascular disease. It remains unknown whether the degree of baroreflex sensitivity and ambulatory blood pressure variability are predictive of the pressor response to sympathoexcitatory stress in healthy humans. In this study the investigators propose a comprehensive evaluation of the relationships among the pressor and forearm vasodilator response to sympathoexcitation, ambulatory blood pressure variability, and baroreflex sensitivity in healthy normotensive subjects. Ultimately this study will provide preliminary data and protocol development for large-scale high resolution phenotyping in population-based trials aimed at determining the functional relevance of candidate gene variation in intermediate physiological traits pertinent to the pathogenesis of hypertension and cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 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

April 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

6.8 years

First QC Date

July 20, 2009

Last Update Submit

January 5, 2016

Conditions

Pressor ResponseBaroreflex SensitivityBlood Pressure VariabilityHeart Rate VariabilityArterial Catecholamines

Keywords

PhysiologyPhenotypeGeneticsGenomicsStressBaroreflexBlood PressureArterial stiffness

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Response to Sympathoexcitation

    On day of study

Secondary Outcomes (1)

  • Baroreflex Sensitivity

    On day of study

Study Arms (1)

All subjects

All subject participants

Other: Physiological maneuvers

Interventions

Physiological maneuversOTHER

These healthy subjects undergo physiological testing, which includes aortic augmentation index, pulse wave velocity, orthostatic stress, baroreflex sensitivity (modified Oxford protocol), mental stress, cold pressor test, isometric handgrip, heart rate variability, 24-hour ambulatory blood pressure monitoring.

All subjects

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents of Southeast Minnesota

You may qualify if:

  • Men age 18-40
  • Non-pregnant women age 18-50

You may not qualify if:

  • Any medical conditions affecting the cardiovascular system
  • Any prescribed chronic medications (except contraceptives)
  • Extremes of fitness (not totally sedentary, not highly exercise-trained)
  • BMI greater than 28

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

  • Ramirez-Marrero FA, Charkoudian N, Hart EC, Schroeder D, Zhong L, Eisenach JH, Joyner MJ. Cardiovascular dynamics in healthy subjects with differing heart rate responses to tilt. J Appl Physiol (1985). 2008 Nov;105(5):1448-53. doi: 10.1152/japplphysiol.90796.2008. Epub 2008 Aug 28.

    PMID: 18756006RESULT

  • Ramirez-Marrero FA, Charkoudian N, Zhong L, Hesse C, Eisenach JH. Balance between sympathetic response to head-up tilt and cardiac vagal factors in healthy humans. Clin Auton Res. 2007 Aug;17(4):227-30. doi: 10.1007/s10286-007-0427-y. Epub 2007 Aug 23.

    PMID: 17717719RESULT

  • Hesse C, Charkoudian N, Liu Z, Joyner MJ, Eisenach JH. Baroreflex sensitivity inversely correlates with ambulatory blood pressure in healthy normotensive humans. Hypertension. 2007 Jul;50(1):41-6. doi: 10.1161/HYPERTENSIONAHA.107.090308. Epub 2007 May 14.

    PMID: 17502489RESULT

Biospecimen

Retention: SAMPLES WITH DNA

serum, white cells

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 22, 2009

Study Start

April 1, 2006

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

US(1)