Autonomic Failure Clinical Trial
Official title:
CO2 Rebreathing to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: A Proof-of-Concept Pilot Study
NCT number | NCT05908760 |
Other study ID # | REB23-0791 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2024 |
Est. completion date | December 2028 |
Neurogenic orthostatic hypotension (nOH) is a chronic condition associated with increased cardiovascular risk and reduced quality of life. On standing, patients with nOH experience a large reduction in blood pressure (BP; at least ≥20/10mmHg, but often much more), which is often accompanied by debilitating symptoms and syncope. A previous study (unpublished) showed that hypercapnia significantly increases standing BP in patients with nOH. Human bodies naturally produce and exhale CO2. Rebreathe devices offer a simple, cost-effective technology to increase arterial CO2. In brief, rebreathe devices work by capturing expired CO2, which is then re-inhaled. The net effect is a transient increase in CO2. A CO2 rebreathing device may offer a novel hemodynamic therapy for patients with nOH. This is a pilot, proof-of-concept study to evaluate a CO2 rebreather to improve blood pressure and orthostatic tolerance in patients with nOH. The hypothesis is that a rebreather will increase CO2 sufficiently enough to improve BP in patients with nOH. Male and female patients (n=28) will be asked to complete two randomized 70° head-up tilt (HUT) tests breathing either room air or using a CO2 rebreather. Hemodynamics (BP, heart rate, stroke volume, brain blood flow) and orthostatic symptoms will be assessed throughout. Breath-by-breath data will include O2, CO2, respiration rate and tidal volume. The primary outcome measure will be the magnitude of the BP response (ΔBP = HUT - Supine) during Room Air vs. Hypercapnia. The primary outcome will be compared between room air and hypercapnia using a paired t-test.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 2028 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Age =18 years - Male and Female - Physician diagnosis of Neurogenic Orthostatic Hypotension - Non-smokers. - Able and willing to provide informed consent. - Ability to travel to Libin Cardiovascular Institute Autonomic Testing Lab at the University of Calgary, Calgary, AB. Exclusion Criteria: - Medical therapies or medications which could interfere with testing of autonomic function - Pregnant or breast-feeding females - Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath. - Presence of failure of other organ systems or systemic illness that can affect autonomic function or the participant's ability to cooperate. These include dementia, alcohol and/or drug abuse, cerebrovascular disease, kidney or liver disease, surgical procedures where the nerves of the sympathetic nervous system have been cut. - Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Freeman R, Abuzinadah AR, Gibbons C, Jones P, Miglis MG, Sinn DI. Orthostatic Hypotension: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Sep 11;72(11):1294-1309. doi: 10.1016/j.jacc.2018.05.079. — View Citation
Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz I, Schondorff R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011 Apr;21(2):69-72. doi: 10.1007/s10286-011-0119-5. No abstract available. — View Citation
Fuglsang CH, Johansen T, Kaila K, Kasch H, Bach FW. Treatment of acute migraine by a partial rebreathing device: A randomized controlled pilot study. Cephalalgia. 2018 Sep;38(10):1632-1643. doi: 10.1177/0333102418797285. Epub 2018 Aug 22. — View Citation
Morgan BJ, Crabtree DC, Palta M, Skatrud JB. Combined hypoxia and hypercapnia evokes long-lasting sympathetic activation in humans. J Appl Physiol (1985). 1995 Jul;79(1):205-13. doi: 10.1152/jappl.1995.79.1.205. — View Citation
Shoemaker JK, Vovk A, Cunningham DA. Peripheral chemoreceptor contributions to sympathetic and cardiovascular responses during hypercapnia. Can J Physiol Pharmacol. 2002 Dec;80(12):1136-44. doi: 10.1139/y02-148. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ? Blood Pressure (BP) | Magnitude of ?BP (HUT-Supine) breathing room air vs CO2 rebreathe | The ?BP (HUT-Supine) calculated as the average BP in the final two minutes of supine baseline and the average BP between minute 3 and 5 of HUT will be compared between room air and CO2 rebreathe | |
Secondary | ? Vanderbilt Orthostatic Symptom Score [Range: 0 (absent) to 10 (worst)] | Magnitude of ? Vanderbilt Orthostatic Symptom Score (HUT-Supine) breathing room air vs CO2 rebreathe | The ? Vanderbilt Orthostatic Symptom Score (symptoms at the 5th minute of HUT - symptoms at the 5th minute of supine rest) will be compared between room air vs CO2 rebreathe | |
Secondary | ? Cerebral Blood Flow Velocity (CBFv) | Magnitude of ?CBFv (HUT-Supine) breathing room air vs CO2 rebreathe | The ?CBFv (HUT-Supine) calculated as the average CBFv in the final two minutes of supine baseline and the average CBFv between minute 3 and 5 of HUT will be compared between room air and CO2 rebreathe |
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