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NCT Number: NCT06751888

Controlled CO2 Inhalation in NOH

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Controlled CO2 delivery

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Cerebral Blood Flow (ΔCBFv)

    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.

  2. Change in Vanderbilt Orthostatic Symptom Scores (ΔVOSS)

    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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Acronym: CO2-nOH

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

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.

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