Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome
NCT ID: NCT01308099
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2011-02-28
2017-01-31
Brief Summary
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The hypothesis of the study is:
Patients with POTS will have vascular endothelial dysfunction compared with control subjects.
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Detailed Description
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Conditions
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Study Design
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CROSS_SECTIONAL
Study Groups
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POTS & Controls
Participants will have a physical prior to the study day and collect urine for 24 hours.
On the study day the following procedures take place:
After blood samples taken (about 2 tbsp), the subject will lie down. A blood pressure cuff will be placed on one arm and small probes on one finger on both hands. The arm blood pressure cuff will be inflated 60 points above the highest number on your normal blood pressure for five minutes. The blood pressure and forearm blood flow will be recorded. At the end of 5 minutes, the cuff will be released and the measurements of blood pressure and calf blood flow will be repeated. The brachial artery diameter and flow will be measured at baseline, during cuff inflation and for 3 minutes after deflation.
The study lasts about 2 hours.
Blood Pressure and Blood Flow
A blood pressure cuff will be placed on one arm and small probes on one finger on both hands. The probes also measure blood pressure. After 10 minutes, the arm blood pressure cuff will be inflated. The cuff will stay inflated for 5 minutes, then the air will be let out. A cuff will be place above the left calf and the left knee. The subject will lie quietly for 9 minutes, then blood pressure and calf blood flow will be measured for one minute. the lower leg cuff will be inflated after 1 minute, then the cuff will be deflated. The blood pressure and forearm blood flow will be recorded. Next, the cuff on the upper leg will be inflated for 5 minutes then, it will be released and the measurements of blood pressure and calf blood flow will be repeated.
The study lasts about 2 hours.
Interventions
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Blood Pressure and Blood Flow
A blood pressure cuff will be placed on one arm and small probes on one finger on both hands. The probes also measure blood pressure. After 10 minutes, the arm blood pressure cuff will be inflated. The cuff will stay inflated for 5 minutes, then the air will be let out. A cuff will be place above the left calf and the left knee. The subject will lie quietly for 9 minutes, then blood pressure and calf blood flow will be measured for one minute. the lower leg cuff will be inflated after 1 minute, then the cuff will be deflated. The blood pressure and forearm blood flow will be recorded. Next, the cuff on the upper leg will be inflated for 5 minutes then, it will be released and the measurements of blood pressure and calf blood flow will be repeated.
The study lasts about 2 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages between 18-60 years old
* Male and female subjects are eligible
* Able and willing to give informed consent
Additional criteria for POTS:
* Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic - Dysfunction Center (1. increase in heart rate \>/= 30 beats/minute with position change from supine to standing for 10 minutes and/or 2. Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence.
Additional criteria for Control subjects:
* Healthy, non-obese, non-smokers without orthostatic tachycardia
* Selected to match profiles of POTS patients (gender, age)
* Not using vasoactive medications
Exclusion Criteria
* Inability to give, or withdraw informed consent
* Pregnancy
* Other factors in the investigator's opinion would prevent the subject from completing the study
18 Years
60 Years
ALL
Yes
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Alfredo Gamboa
Research Assistant Professor of Medicine
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Countries
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References
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Masuki S, Eisenach JH, Schrage WG, Johnson CP, Dietz NM, Wilkins BW, Sandroni P, Low PA, Joyner MJ. Reduced stroke volume during exercise in postural tachycardia syndrome. J Appl Physiol (1985). 2007 Oct;103(4):1128-35. doi: 10.1152/japplphysiol.00175.2007. Epub 2007 Jul 12.
Roberts LJ 2nd, Morrow JD. Isoprostanes. Novel markers of endogenous lipid peroxidation and potential mediators of oxidant injury. Ann N Y Acad Sci. 1994 Nov 15;744:237-42. doi: 10.1111/j.1749-6632.1994.tb52741.x.
Epel ES, Blackburn EH, Lin J, Dhabhar FS, Adler NE, Morrow JD, Cawthon RM. Accelerated telomere shortening in response to life stress. Proc Natl Acad Sci U S A. 2004 Dec 7;101(49):17312-5. doi: 10.1073/pnas.0407162101. Epub 2004 Dec 1.
Medow MS, Minson CT, Stewart JM. Decreased microvascular nitric oxide-dependent vasodilation in postural tachycardia syndrome. Circulation. 2005 Oct 25;112(17):2611-8. doi: 10.1161/CIRCULATIONAHA.104.526764. Epub 2005 Oct 17.
Kuvin JT, Patel AR, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE. Assessment of peripheral vascular endothelial function with finger arterial pulse wave amplitude. Am Heart J. 2003 Jul;146(1):168-74. doi: 10.1016/S0002-8703(03)00094-2.
Rozanski A, Qureshi E, Bauman M, Reed G, Pillar G, Diamond GA. Peripheral arterial responses to treadmill exercise among healthy subjects and atherosclerotic patients. Circulation. 2001 Apr 24;103(16):2084-9. doi: 10.1161/01.cir.103.16.2084.
Meredith IT, Currie KE, Anderson TJ, Roddy MA, Ganz P, Creager MA. Postischemic vasodilation in human forearm is dependent on endothelium-derived nitric oxide. Am J Physiol. 1996 Apr;270(4 Pt 2):H1435-40. doi: 10.1152/ajpheart.1996.270.4.H1435.
Dakak N, Husain S, Mulcahy D, Andrews NP, Panza JA, Waclawiw M, Schenke W, Quyyumi AA. Contribution of nitric oxide to reactive hyperemia: impact of endothelial dysfunction. Hypertension. 1998 Jul;32(1):9-15. doi: 10.1161/01.hyp.32.1.9.
Higashi Y, Sasaki S, Nakagawa K, Matsuura H, Kajiyama G, Oshima T. A noninvasive measurement of reactive hyperemia that can be used to assess resistance artery endothelial function in humans. Am J Cardiol. 2001 Jan 1;87(1):121-5, A9. doi: 10.1016/s0002-9149(00)01288-1.
Wilkinson IB, Qasem A, McEniery CM, Webb DJ, Avolio AP, Cockcroft JR. Nitric oxide regulates local arterial distensibility in vivo. Circulation. 2002 Jan 15;105(2):213-7. doi: 10.1161/hc0202.101970.
Noon JP, Haynes WG, Webb DJ, Shore AC. Local inhibition of nitric oxide generation in man reduces blood flow in finger pulp but not in hand dorsum skin. J Physiol. 1996 Jan 15;490 ( Pt 2)(Pt 2):501-8. doi: 10.1113/jphysiol.1996.sp021161.
Nohria A, Gerhard-Herman M, Creager MA, Hurley S, Mitra D, Ganz P. Role of nitric oxide in the regulation of digital pulse volume amplitude in humans. J Appl Physiol (1985). 2006 Aug;101(2):545-8. doi: 10.1152/japplphysiol.01285.2005. Epub 2006 Apr 13.
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.
Dupont WD, Plummer WD. PS power and sample size program available for free on the internet. Control Clin Trials 1997;18:274
Chopoorian AH, Wahba A, Celedonio J, Nwazue V, Smith EC, Garland EM, Paranjape S, Okamoto LE, Black BK, Biaggioni I, Raj SR, Gamboa A. Impaired Endothelial Function in Patients With Postural Tachycardia Syndrome. Hypertension. 2021 Mar 3;77(3):1001-1009. doi: 10.1161/HYPERTENSIONAHA.120.16238. Epub 2021 Jan 25.
Other Identifiers
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091332
Identifier Type: -
Identifier Source: org_study_id
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