Clinical trial NCT00962728: Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)
Official title: Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome
Keywords: heart rate
tachycardia
orthostatic intolerance
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2009-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with postural tachycardia syndrome.

Detailed description: Chronic orthostatic intolerance, sometimes known as the postural tachycardia syndrome (POTS), is the most common disorder among patients seen at several centers specializing in diseases of the autonomic nervous system. It affects an estimated 500,000 people in the United States alone. POTS (excessive increase in heart rate \[\>30 min-1\] on standing associated with orthostatic symptoms \[including palpitation, chest pain syndrome, dyspnea on standing, mental clouding and difficulties with concentration\], in the absence of orthostatic hypotension) can produce substantial disability among otherwise healthy people. Patients with POTS typically feel tired and run down. Many also report a myriad of symptoms that are hard to categorize, often involving fatigue. One study, from the Mayo Clinic, found that patients with POTS had a diminished quality of life when measured using a standard health status instrument (SF-36).

In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic tachycardia in patients with postural tachycardia syndrome.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
* Increase in heart rate ≥ 30 beats/min with position change from supine to standing (10 minutes)
* Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
* Able and willing to provide informed consent

Exclusion Criteria:

* Overt cause for postural tachycardia (such as acute dehydration)
* Inability to give, or withdrawal of, informed consent
* Pregnant
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Primary outcomes:
measure: Magnitude of orthostatic heart rate increase on upright posture
timeFrame: 10 min
Secondary outcomes:
measure: Symptoms rating with upright posture
timeFrame: 10 min
measure: Hemodynamic changes on upright posture
timeFrame: 10 min
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Convertino VA, Ryan KL, Rickards CA, Cooke WH, Idris AH, Metzger A, Holcomb JB, Adams BD, Lurie KG. Inspiratory resistance maintains arterial pressure during central hypovolemia: implications for treatment of patients with severe hemorrhage. Crit Care Med. 2007 Apr;35(4):1145-52. doi: 10.1097/01.CCM.0000259464.83188.2C.
citation: Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.
citation: Gamboa A, Paranjape SY, Black BK, Arnold AC, Figueroa R, Okamoto LE, Nwazue VC, Diedrich A, Plummer WD, Dupont WD, Robertson D, Raj SR. Inspiratory resistance improves postural tachycardia: a randomized study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):651-8. doi: 10.1161/CIRCEP.114.002605. Epub 2015 Mar 19.