An interventional study of Controlled CO2 delivery and Controlled CO2 delivery (Sham) in Neurogenic Orthostatic Hypotension, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
This study focuses on neurogenic orthostatic hypotension (nOH), which is a disorder characterized by an abnormal drop in blood pressure (BP) within 3-minutes of standing. Patients with nOH experience debilitating symptoms including light-headedness, falls, and fainting. Patients often struggle with day-to-day tasks that require standing, with a reduced quality-of-life. Current therapies for nOH have limited effectiveness and unwanted side effects. Our lab has found that raising blood CO2 levels (hypercapnia) in the lab increases BP when standing in patients with nOH. We now aim to test the CarboHaler, an exogenous controlled CO2 delivery device, in this study to see if increasing CO2 levels through controlled CO2 inhalation can improve BP and reduce symptoms in patients with nOH when standing up. On the study day, participants will undergo two Head-up Tilt (HUT; upright) tests with different breathing protocols: one with and one without exogenous CO2 delivery provided by a CO2 inhalational device. We will record heart rate, blood pressure, and breathing parameters. We will also assess upright symptoms using the Vanderbilt Orthostatic Symptoms Score. Our primary outcome is the magnitude of the change in systolic BP from lying down to standing, which will be compared with and without exogenous CO2 delivery. We hypothesize that exogenous CO2 delivery provided by a CO2 inhalational device will raise CO2 enough to increase standing BP, which could reduce the debilitating symptoms experienced by patients with nOH. We hope that these data will support future clinical trials, with the long-term goal of creating a simple, low-cost treatment for increasing quality-of-life for patients with nOH.
155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.
This study's planned enrollment of 28 is close to the median of 30 across 113 interventional studies indexed under Hypotension, Orthostatic.
Browse Hypotension, Orthostatic studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
In this arm, participants will breathe with the CO2 delivery device providing no exogenous CO2 while supine and during a 10-min HUT test.
Device: Controlled CO2 delivery (Sham)
In this arm, participants will breathe with the CO2 delivery device in the supine position until BP levels increase. Once a BP increase is observed, participants will be tilted upright and will continue to breathe with the inhalation device during a 10-min HUT test.
Other: Controlled CO2 delivery
The use of a controlled CO2 delivery offers a straightforward way to increase arterial CO2. Controlled CO2 inhalation may offer a novel hemodynamic therapy for patients with Neurogenic Orthostatic Hypotension
For this intervention, we will be using this device set at 0% CO2 for our sham comparison.
Magnitude of the systolic blood pressure (SBP) response
The primary outcome measures will be the magnitude of the systolic blood pressure (SBP) response (ΔSBP = Head Up Tilt - Supine) during 0% CO2 vs. Controlled CO2 inhalation.
Time frame: Start of in-lab study day to the end of the in-lab study day
Change in Cerebral Blood Flow (ΔCBFv)
Secondary outcome measures will be the change in Cerebral Blood Flow (ΔCBFv) for each arm of the study.
Time frame: Start of in-lab study day to the end of the in-lab study day
Change in Vanderbilt Orthostatic Symptom Scores (ΔVOSS)
Secondary outcome measures will be the change in Vanderbilt Orthostatic Symptom Scores (ΔVOSS) for each arm of the study.
Time frame: Start of in-lab study day to the end of the in-lab study day
Plan to share: No
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Calgary