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Clinical Trial

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

NCT: NCT05908760 · RECRUITING

NCT IDNCT05908760
StatusRECRUITING
Start Date2024-07-30
Completion2030-12-31

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 A previous study (unpublished) showed that hypercapnia significantly increases standing BP in patients with nOH.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

Frequently Asked Questions

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

CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study is a clinical trial registered under NCT05908760. Current status: RECRUITING.

What is the status of NCT05908760?

The current status of NCT05908760 (CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study) is: RECRUITING.

When did CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study start?

CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study started on 2024-07-30.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.