High Resolution Phenotyping in Healthy Humans
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ClinicalTrials.gov Identifier: NCT00943774 |
Recruitment Status :
Completed
First Posted : July 22, 2009
Last Update Posted : January 6, 2016
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Tracking Information | |||
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First Submitted Date | July 20, 2009 | ||
First Posted Date | July 22, 2009 | ||
Last Update Posted Date | January 6, 2016 | ||
Study Start Date | April 2006 | ||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
Blood Pressure Response to Sympathoexcitation [ Time Frame: On day of study ] | ||
Original Primary Outcome Measures | Same as current | ||
Change History | |||
Current Secondary Outcome Measures |
Baroreflex Sensitivity [ Time Frame: On day of study ] | ||
Original Secondary Outcome Measures | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | High Resolution Phenotyping in Healthy Humans | ||
Official Title | Blood Pressure Variability, Baroreflex Sensitivity, and Cardiovascular Responses to Sympathoexcitation in Healthy Normotensive Humans | ||
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. | ||
Detailed Description | Growing evidence suggests an association of environmental stress with the development of hypertension and there is strong evidence in normotensive subjects that a greater pressor response to sympathoexcitatory stress is a harbinger of future hypertension. Pharmacological studies have shown that individuals with HTN have a blunted baroreflex sensitivity, and display a greater increase in blood pressure during administration of an alpha-agonist. Furthermore, exaggerated 24-hour ambulatory blood pressure variability (BPV) is proposed to be a risk factor for the development of cardiovascular disease. Finally, Beta-2 adrenergic receptor-mediated forearm vasodilator responses to mental stress are blunted in Caucasian subjects at increased risk for hypertension, in African Americans, and in mild hypertension. We postulate that a relationship exists between these variables, even in normotensive healthy individuals. We also believe that signs of subclinical metabolic dysfunction exist in healthy individuals and that they may either contribute to or be affected by BPV. There is also evidence the prematurity at birth and low birth weight are associated with hypertension. Finally, arterial stiffness may also be related to blood pressure variability and the pressor response. Therefore the specific aims of this study are:
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Study Type | Observational | ||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||
Biospecimen | Retention: Samples With DNA Description: serum, white cells
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Sampling Method | Non-Probability Sample | ||
Study Population | Residents of Southeast Minnesota | ||
Condition |
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Intervention | Other: Physiological maneuvers
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.
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Study Groups/Cohorts | All subjects
All subject participants
Intervention: Other: Physiological maneuvers
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
300 | ||
Original Estimated Enrollment | Same as current | ||
Actual Study Completion Date | February 2013 | ||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT00943774 | ||
Other Study ID Numbers | 05-004352 R01HL089331 ( U.S. NIH Grant/Contract ) NS-32352 |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | John Eisenach, Mayo Clinic | ||
Study Sponsor | Mayo Clinic | ||
Collaborators | National Heart, Lung, and Blood Institute (NHLBI) | ||
Investigators | Not Provided | ||
PRS Account | Mayo Clinic | ||
Verification Date | January 2016 |