University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Location contact
Rasha Hamzeh, RN
CONTACT
Satish Raj, MD MSCI
CONTACT
NCT Number: NCT06751888
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Calgary, Alberta, T2N 4Z6, Canada
Rasha Hamzeh, RN
CONTACT
Satish Raj, MD MSCI
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Start of in-lab study day to the end of the in-lab study day
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
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
Secondary outcome measures will be the change in Vanderbilt Orthostatic Symptom Scores (ΔVOSS) for each arm of the study.
University of Calgary
Other
Controlled CO2 Inhalation to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: a Proof-of-Concept Novel Therapy Study
Acronym: CO2-nOH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07706829
Anosmia, Basal Ganglia Diseases
Toulouse, France
View Trial DetailsNCT07089043
Neurogenic Orthostatic Hypotension
Scottsdale, Arizona, United States
View Trial DetailsNCT01799915
Autonomic Nervous System Diseases, Basal Ganglia Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT05908760
Autonomic Failure, Autonomic Nervous System Diseases
Calgary, Alberta, Canada
View Trial Details