Controlled CO2 Inhalation in NOH

Официальное название

Controlled CO2 Inhalation to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: a Proof-of-Concept Novel Therapy Study

Обзор

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.

Вмешательства

• Другое Controlled CO2 delivery
  The use of a controlled CO2 delivery offers a straightforward way to increase arterial CO2. Controlled CO2 inhalation may offer a novel hemodynamic therapy for patients with Neurogenic Orthostatic Hypotension
• Устройство Controlled CO2 delivery (Sham)
  For this intervention, we will be using this device set at 0% CO2 for our sham comparison.

Первичные конечные точки

• Magnitude of the systolic blood pressure (SBP) response [Срок оценки: Start of in-lab study day to the end of the in-lab study day]

Вторичные конечные точки (2)

• Change in Cerebral Blood Flow (ΔCBFv) [Срок оценки: Start of in-lab study day to the end of the in-lab study day]
• Change in Vanderbilt Orthostatic Symptom Scores (ΔVOSS) [Срок оценки: Start of in-lab study day to the end of the in-lab study day]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Calgary — Calgary

Идентификаторы

NCT: NCT06751888 · REB24-1780

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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