Neurogenic Orthostatic HypotensionCO2-nOHNCT06751888
Controlled CO2 Inhalation in NOH
A study of Neurogenic Orthostatic Hypotension, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Orthostatic Hypotension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Calgary
Calgary, Alberta, T2N 4Z6
Satish Raj, MD MSCI, 4032106152, autonomic.research@ucalgary.ca
Rasha Hamzeh, RN, 4032208897, autonomic.research@ucalgary.ca
About this study
Official title: Controlled CO2 Inhalation to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: a Proof-of-Concept Novel Therapy Study
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.
- Conditions
- Neurogenic Orthostatic Hypotension
- Being tested
- Controlled CO2 delivery, Controlled CO2 delivery (Sham)
- Keywords
- Neurogenic Orthostatic Hypotension, Autonomic, Cardiovascular, Therapies, Quality-of-life, Symptom-management, Novel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled CO2 deliveryOther
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
Controlled CO2 delivery (Sham)Device
For this intervention, we will be using this device set at 0% CO2 for our sham comparison.
| Study group | Role | What they receive |
|---|---|---|
| 0% CO2 Arm | Sham comparator | In this arm, participants will breathe with the CO2 delivery device providing no exogenous CO2 while supine and during a 10-min HUT test. Receives: Device: Controlled CO2 delivery (Sham) |
| Controlled CO2 Inhalation Arm | Experimental | 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. Receives: Other: Controlled CO2 delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of in-lab study day to the end of the in-lab study day
Secondary outcomes (2)
Change in Cerebral Blood Flow (ΔCBFv)
Secondary outcome measures will be the change in Cerebral Blood Flow (ΔCBFv) for each arm of the study.
Measured: 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.
Measured: Start of in-lab study day to the end of the in-lab study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751888
- Sponsor's protocol ID
- REB24-1780
- Acronym
- CO2-nOH
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled CO2 Inhalation to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: a Proof-of-Concept Novel Therapy Study
- ClinicalTrials.gov ID
- NCT06751888
- Acronym / sponsor ID
- CO2-nOH / REB24-1780
- Conditions
- Neurogenic Orthostatic Hypotension
- Keywords
- Neurogenic Orthostatic Hypotension, Autonomic, Cardiovascular, Therapies, Quality-of-life, Symptom-management, Novel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0% CO2 Arm | Sham comparator | Device: Controlled CO2 delivery (Sham)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 Inhalation Arm | Experimental | Other: Controlled CO2 deliveryIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Male and Female
- Physician diagnosis of Neurogenic Orthostatic Hypotension
- Non-smokers.
- Able and willing to provide informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled CO2 deliveryThe 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 | Other | Controlled CO2 Inhalation Arm |
| Controlled CO2 delivery (Sham)For this intervention, we will be using this device set at 0% CO2 for our sham comparison. | Device | 0% CO2 Arm |
Primary outcome
Magnitude of the systolic blood pressure (SBP) response
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.
2 secondary outcomes
Change in Cerebral Blood Flow (ΔCBFv)
Time frame: Start of in-lab study day to the end of the in-lab study day
Change in Vanderbilt Orthostatic Symptom Scores (ΔVOSS)
Time frame: Start of in-lab study day to the end of the in-lab study day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neurogenic Orthostatic Hypotension, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of the systolic blood pressure (SBP) response (time frame: Start of in-lab study day to the end of the in-lab study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.