Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome

NCT01308099 | Completed

• 1 other identifier: 091332
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have different levels of certain chemicals in their blood than people who don't have POTS. This study will test whether the blood vessels of people with POTS will react differently to certain tests than people without POTS. The hypothesis of the study is: Patients with POTS will have vascular endothelial dysfunction compared with control subjects.

Conditions

Postural Tachycardia Syndrome

Keywords

POTS; Vascular Endothelial Function

Outcome Measures

Primary Outcomes (1)

• RH-PAT index

  The primary analysis of RH-PAT will involve a non-parametric, Mann Whitney U test of RH-PAT between POTS patients and Control subjects.

  The study will be complete in approximately 2 hours. There is no follow-up to this study.

Study Arms (1)

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.

Device: Blood Pressure and Blood Flow

Interventions

Blood Pressure and Blood Flow DEVICE

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.

Also known as: Pulsitile Arterial Tonometry Protocol (PAT)

POTS & Controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with Postural Tachycardia Syndrome Controls will be age \& sex matched to the patients with POTS

You may qualify if:

• ALL:
• 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

You may not qualify if:

• Overt cause for postural tachycardia (such as acute dehydration)
• Inability to give, or withdraw informed consent
• Pregnancy
• Other factors in the investigator's opinion would prevent the subject from completing the study

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (2)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (15)

• 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.

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  PMID: 16230486 BACKGROUND

• 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.

  PMID: 12851627 BACKGROUND

• 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.

  PMID: 11319199 BACKGROUND

• 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.

  PMID: 8967386 BACKGROUND

• 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.

  PMID: 9674631 BACKGROUND

• 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.

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• 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.

  PMID: 11790703 BACKGROUND

• 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.

  PMID: 8821146 BACKGROUND

• 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.

  PMID: 16614356 BACKGROUND

• 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.

  PMID: 15582310 BACKGROUND

• Dupont WD, Plummer WD. PS power and sample size program available for free on the internet. Control Clin Trials 1997;18:274

  BACKGROUND

• 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.

  PMID: 33486983 DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: March 3, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)