Using a CO2 rebreather to improve blood pressure in patients with neurogenic orthostatic hypotension
CO2 Rebreathing to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: A Proof-of-Concept Pilot Study
This study is testing whether a CO2 rebreather can help people with neurogenic orthostatic hypotension improve their blood pressure and feel better when standing up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05908760 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of a CO2 rebreather device in improving blood pressure and orthostatic tolerance in patients diagnosed with neurogenic orthostatic hypotension (nOH). The study is based on the hypothesis that increasing arterial CO2 levels through rebreathing can enhance blood pressure responses in these patients. The intervention involves capturing and re-inhaling expired CO2 to transiently elevate CO2 levels, potentially offering a novel treatment approach for managing nOH symptoms. The study will include 28 participants who meet specific eligibility criteria and will be conducted at the University of Calgary.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a physician diagnosis of neurogenic orthostatic hypotension.
Not a fit: Patients with chronic heart failure, severe pulmonary disease, or other systemic illnesses affecting autonomic function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood pressure regulation and quality of life for patients suffering from neurogenic orthostatic hypotension.
How similar studies have performed: While this approach is novel, previous studies have indicated that hypercapnia can improve blood pressure in patients with nOH, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Medical therapies or medications which could interfere with testing of autonomic function * 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, cerebrovascular disease, kidney or liver disease, surgical procedures where the nerves of the sympathetic nervous system have been cut. * Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Satish R Raj, MD — University of Calgary
- Study coordinator: Jacquie Baker, PhD
- Email: autonomic.research@ucalgary.ca
- Phone: 4032103819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.