beta
Trial Radar AI
Clinical Trial NCT06751888 (CO2-nOH) for Neurogenic Orthostatic Hypotension is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One trial matched filter criteria
Card View
Back to Search

Controlled CO2 Inhalation in NOH (CO2-nOH)

Not yet recruiting
Clinical Trial NCT06751888 (CO2-nOH) is an interventional study for Neurogenic Orthostatic Hypotension is not yet recruiting. Enrollment is planned to begin on 1 May 2025 until the trial accrues 28 participants. Led by University of Calgary, this trial is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 30 December 2024.
Brief Summary
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.
Official Title

Controlled CO2 Inhalation to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: a Proof-of-Concept Novel Therapy Study

Conditions
Neurogenic Orthostatic Hypotension
Other Study IDs
  • CO2-nOH
  • REB24-1780
NCT ID Number
NCT06751888
Start Date (Actual)
2025-05-01
Last Update Posted
2024-12-30
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
28
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Neurogenic Orthostatic Hypotension
Autonomic
Cardiovascular
Therapies
Quality-of-life
Symptom-management
Novel
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Sham Comparator0% CO2 Arm
In this arm, participants will breathe with the CO2 delivery device providing no exogenous CO2 while supine and during a 10-min HUT test.
Controlled CO2 Delivery (Sham)
For this intervention, we will be using this device set at 0% CO2 for our sham comparison.
ExperimentalControlled CO2 Inhalation Arm
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.
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Start of in-lab study day to the end of the in-lab study day
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Cerebral Blood Flow (ΔCBFv)
Secondary outcome measures will be the change in Cerebral Blood Flow (ΔCBFv) for each arm of the study.
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.
Start of in-lab study day to the end of the in-lab study day
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
  • Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.
University of Calgary logoUniversity of Calgary226 active trials to explore
No contact data.
1 Study Locations in 1 Countries

Alberta

University of Calgary, Calgary, Alberta, T2N 4Z6, Canada
Satish Raj, MD MSCI, Contact, 4032106152, [email protected]
Rasha Hamzeh, RN, Contact, 4032208897, [email protected]