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CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study

RecruitingNAAges 18 Years - 100 YearsAllUniversity of Calgary
NCT05908760 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 A previous study (unpublished) showed that hypercapnia significantly increases standing BP in patients with nOH.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 orthos

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📋 Eligibility rules (as published)
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.
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What it tests

  • CO2 ReHaler
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Where

1 site
University of Calgary
Calgary, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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