Controlled CO2 Inhalation in NOH

Last updated: December 20, 2024
Sponsor: University of Calgary
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Circulation Disorders

Dizzy/fainting Spells

Vascular Diseases

Treatment

Controlled CO2 delivery (Sham)

Controlled CO2 delivery

Clinical Study ID

NCT06751888
REB24-1780
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theUniversity of Calgary, Calgary, AB.

Exclusion

Exclusion Criteria:

  • Pregnant or breast-feeding females

  • Subjects with chronic heart failure or severe pulmonary disease who are unable toclimb one flight of stairs due to shortness of breath.

  • Presence of failure of other organ systems or systemic illness that can affectautonomic function or the participant's ability to cooperate. These includedementia, alcohol and/or drug abuse.

  • Other factors which in the investigator's opinion would prevent the participant fromcompleting the protocol, including poor compliance during previous studies.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Controlled CO2 delivery (Sham)
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

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