Clinical trial NCT00962884: Breathing Device for Orthostatic Hypotension (OH)
Official title: Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orthostatic Hypotension
Keywords: Orthostatic hypotension
Breathing
Blood pressure
standing
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2009-08-20
Enrollment: 0
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: TREATMENT

Brief summary: The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease blood pressure drops on standing in patients with orthostatic hypotension.

Detailed description: Orthostatic hypotension is commonly described, especially in an elderly population. Using data from a national hospital inpatient database, Shibao et al. have reported that the annual hospitalization rate for orthostatic hypotension was 233 per 100000 among patients older than 75 years. Orthostatic hypotension is associated with an increased risk of falls, increased risk of coronary heart disease and mortality.

Orthostatic hypotension is defined as a fall in systolic blood pressure of at least 20 mmHg within 3 minutes upon standing 3. Patients with orthostatic hypotension commonly experience lightheadedness or syncope. In normal individuals, changes in posture do not results in significant changes in blood pressure due to physiological compensation for the gravity-mediated pooling of blood in the lower limbs with upright posture. Unfortunately, in patients with impairments of the autonomic nervous system, one or more of these adaptive mechanisms fail, and an orthostatic fall in blood pressure results.

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

Eligibility criteria: Inclusion Criteria:

* Diagnosed with neurogenic orthostatic hypotension by the Vanderbilt Autonomic Dysfunction Center
* Decrease in systolic blood pressure ≥ 20 mmHg with position change from supine to standing (10 minutes)
* Evidence of reproducibility suggestive of non-reversible nervous system origin for the orthostatic hypotension
* Age between 18-80 years
* Male and female subjects are eligible
* Able and willing to provide informed consent

Exclusion Criteria:

* Overt cause for orthostatic hypotension (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 drop in Systolic Blood Pressure during head-up tilt
timeFrame: 1 min
Secondary outcomes:
measure: "Standing Time" tolerated with systolic blood pressure above 70 mmHg
timeFrame: 10 min (max)
measure: Symptom rating
timeFrame: 10 min (max)
measure: Hemodynamics (non-invasive)
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: Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009.