Orthostatic Hypotension Clinical Trial
Official title:
Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension
NCT number | NCT00962884 |
Other study ID # | 090600 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2010 |
Est. completion date | December 2022 |
Verified date | November 2021 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Alfredo Gamboa | Vanderbilt University Medical Center |
United States,
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. Epub 2005 Apr 28. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Magnitude of drop in Systolic Blood Pressure during head-up tilt | 1 min | ||
Secondary | "Standing Time" tolerated with systolic blood pressure above 70 mmHg | 10 min (max) | ||
Secondary | Symptom rating | 10 min (max) | ||
Secondary | Hemodynamics (non-invasive) | 10 min |
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