CO2 Rebreathing to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: A Proof-of-Concept Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Neurogenic orthostatic hypotension (nOH) is a chronic condition associated with increased cardiovascular risk and reduced quality of life. On standing, patients with nOH experience a large reduction in blood pressure (BP; at least ≥20/10mmHg, but often much more), which is often accompanied by debilitating symptoms and syncope. A previous study (unpublished) showed that hypercapnia significantly increases standing BP in patients with nOH. Human bodies naturally produce and exhale CO2. Rebreathe devices offer a simple, cost-effective technology to increase arterial CO2. In brief, rebreathe devices work by capturing expired CO2, which is then re-inhaled. The net effect is a transient increase in CO2. A CO2 rebreathing device may offer a novel hemodynamic therapy for patients with nOH. This is a pilot, proof-of-concept study to evaluate a CO2 rebreather to improve blood pressure and orthostatic tolerance in patients with nOH. The hypothesis is that a rebreather will increase CO2 sufficiently enough to improve BP in patients with nOH. Male and female patients (n=28) will be asked to complete two randomized 70° head-up tilt (HUT) tests breathing either room air or using a CO2 rebreather. Hemodynamics (BP, heart rate, stroke volume, brain blood flow) and orthostatic symptoms will be assessed throughout. Breath-by-breath data will include O2, CO2, respiration rate and tidal volume. The primary outcome measure will be the magnitude of the BP response (ΔBP = HUT - Supine) during Room Air vs. Hypercapnia. The primary outcome will be compared between room air and hypercapnia using a paired t-test.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University of Calgary
RECRUITING
Calgary
Contact Information
Primary
Jacquie Baker, PhD
autonomic.research@ucalgary.ca
4032107629
Backup
Tanya Siddiqui, MD
autonomic.research@ucalgary.ca
4032107629
Time Frame
Start Date: 2024-05-05
Estimated Completion Date: 2028-12
Participants
Target number of participants: 28
Treatments
Experimental: CO2 Rebreathing
Participants will breathe with the rebreather in the supine position until CO2 levels increase between 5-10mmHg. Once CO2 levels are increased, participants will be tilted upright, and will continue to breathe with the rebreather during a 5-min HUT test
No_intervention: Room Air
Participants will breathe room air in the supine position and during a 5-min HUT test
Sponsors
Leads: University of Calgary

This content was sourced from clinicaltrials.gov