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Last update 23 Jan 2025

Neurogenic Orthostatic Hypotension

Last update 23 Jan 2025

Basic Info

Synonyms

Neurogenic Orthostatic Hypotension, Neurogenic orthostatic hypotension (nOH), hypotension; orthostatic, neurogenic

+ [1]

Introduction

Orthostatic hypotension due to autonomic dysfunction. Primary neurogenic orthostatic hypotension (nOH) may be associated with disorders such as Parkinson disease (PD) and multiple system atrophy (MSA) whereas secondary nOH may be seen in peripheral neuropathies.

Drugs associated with Neurogenic Orthostatic Hypotension

Midodrine Hydrochloride

Target

ADRA1

Mechanism

ADRA1 agonists

Active Org.

Taisho Pharmaceutical Co., Ltd. [+5]

Originator Org.

Shire Plc

Active Indication

Hypotension [+1]

Inactive Indication

Fatigue Syndrome, Chronic [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date29 Jun 1989

Droxidopa

Target

adrenergic receptor

Mechanism

adrenergic receptor agonists

Active Org.

Sumitomo Pharma Co., Ltd. [+2]

Originator Org.

Sumitomo Pharma Co., Ltd.

Active Indication

Diabetic Neuropathies [+6]

Inactive Indication

Attention Deficit Disorder With Hyperactivity [+14]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date17 Jan 1989

Ampreloxetine hydrochloride

Target

NET x SERT

Mechanism

NET inhibitors [+1]

Active Org.

Theravance Biopharma, Inc.

Originator Org.

Theravance Biopharma, Inc.

Active Indication

Multiple System Atrophy [+1]

Inactive Indication

Attention Deficit Disorder With Hyperactivity [+5]

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date20 Jan 1800

Clinical Trials associated with Neurogenic Orthostatic Hypotension

NCT06751888

/ Not yet recruitingNot Applicable

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

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.

Start Date01 May 2025

Sponsor / Collaborator

University of Calgary

NCT05908760

/ RecruitingNot Applicable

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

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.

Start Date05 May 2024

Sponsor / Collaborator

University of Calgary

NCT05696717

/ RecruitingPhase 3

A Phase 3, Multi-center, Randomized Withdrawal and Long Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Start Date27 Jun 2023

Sponsor / Collaborator

Theravance Biopharma, Inc.

100 Clinical Results associated with Neurogenic Orthostatic Hypotension

100 Translational Medicine associated with Neurogenic Orthostatic Hypotension

0 Patents (Medical) associated with Neurogenic Orthostatic Hypotension

419

Literatures (Medical) associated with Neurogenic Orthostatic Hypotension

01 Jan 2025·Hypertension

Cerebral Blood Flow Dynamics in Neurogenic Orthostatic Hypotension: A Systematic Review and Meta-Analysis

Review

Author: Patel, Aishani ; Gewandter, Jennifer ; Beach, Paul A. ; Baker, Jacquie R. ; Tan, Can Ozan ; Ranada, Shaun I. ; Freeman, Roy ; Raj, Satish R.

BACKGROUND:Neurogenic orthostatic hypotension (nOH) causes pathological falls in standing blood pressure that may or may not be symptomatic. nOH also raises the risk of poor neurological outcomes irrespective of symptom presence, possibly reflecting subclinical cerebral hypoperfusion. Dynamic changes in cerebral blood flow velocity (CBFv) help infer how blood pressure fluctuations influence CBFv and cerebral autoregulation. Whether CBFv is impacted in nOH relative to related conditions without nOH and healthy controls (HC) remains unresolved. Whether nOH symptoms reflect greater CBFv falls is also unclear. This review aimed to compare CBFv between nOH and HC, nOH and disease-matched controls (eg, Parkinson disease±nOH), and between symptomatic and asymptomatic nOH.METHODS:Embase and MEDLINE were searched up to April 2024. Means, SDs, and sample sizes for supine and upright CBFv were extracted to generate standardized effect sizes (Hedge g). Random-effects modeling compared postintervention between-group effect sizes.RESULTS: Seventeen studies were included for review. Thirteen studies were suitable for meta-analysis comparing nOH to HC, 2 comparing disease-matched controls to nOH and to HC, and 3 for symptomatic comparisons. Compared with HC, nOH had larger drops in CBFv (Hedge g, −0.64 [95% CI, −0.85 to −0.44]; P <0.001). CBFv falls between nOH and disease-matched controls were similar ( P =0.17). Symptomatic nOH had larger CBFv drops (Hedge g, 0.84 [95% CI, 0.212–1.461]; P =0.009) than asymptomatic nOH. CONCLUSIONS:nOH causes significant orthostatic reductions in CBFv compared with HC, and symptomatic patients experience greater falls in CBFv than asymptomatic patients. Recognizing the clinical implications of CBFv in nOH is crucial for mitigating adverse outcomes.

05 Dec 2024·Cureus

A Case of Severe Advanced Diabetic Cardiac Autonomic Neuropathy: Severe Orthostatic Hypotension Complicated With Episodes of Nocturnal Supine Hypertensive Emergency Episodes

Article

Author: Myint, Nyan

Diabetic cardiac autonomic neuropathy (CAN) is caused by damage to the autonomic nerve fibers that innervate the heart and blood vessels, leading to abnormalities in heart rate control and vascular dynamics. CAN encompasses symptoms such as exercise intolerance, orthostatic hypotension, cardiac denervation syndrome, and nocturnal hypertension. Neurogenic orthostatic hypotension (nOH), resulting from severe diabetic CAN, can cause symptomatic orthostatic hypotension. The management of orthostatic hypotension primarily focuses on preventing severe symptoms, such as syncope and falls. It is equally important to address nocturnal supine hypertension, as it can exacerbate morning orthostatic hypotension. The management strategies for these conditions often complicate each other, highlighting the intricate and delicate nature of treating severe orthostatic hypotension associated with diabetic CAN. We present the case of a 55-year-old male with symptomatic orthostatic hypotension and coexisting nocturnal supine hypertension caused by severe, advanced diabetic CAN.

01 Dec 2024·Journal of Hypertension

Abnormal brain-heart electrophysiology in mild and severe orthostatic hypotension

Article

Author: Zhang, Jiejun ; Huang, Peilin ; Pan, Xiaodong ; Lin, Lin ; Cheng, Yingzhe ; Wang, Yanping ; Zheng, Jiahao ; Cheng, Yahui

Introduction:This study investigated the changes in cardiocerebral electrophysiology in patients with mild orthostatic hypotension (MOH) and severe orthostatic hypotension (SOH) and their relationship with the severity of orthostatic hypotension, psychiatric symptoms, and cognitive dysfunction.Methods:This study included 72 nonorthostatic hypotension (NOH), 17 with MOH, and 11 with SOH. Seated resting-state heart rate variability (HRV) and quantitative electroencephalogram parameters were synchronized and recorded. HRV measures in the time and frequency domains were analyzed, along with the peak frequency and power of the brain waves.Results:Abnormal neuronal activity was found in FP1 in patients with MOH, whereas it was more widespread in FP1, FP2, and O2 in patients with SOH (P < 0.05). Cardiac and cerebral electrophysiological abnormalities were significantly associated with orthostatic hypotension severity, psychiatric symptoms, and cognitive dysfunction.Conclusion:Abnormal EEG activity in patients are mainly manifested in the prefrontal and occipital lobes, especially in patients with SOH. These results may help patients to better understand the mechanisms underlying orthostatic hypotension severity and psychiatric and cognitive impairment in orthostatic hypotension.

News (Medical) associated with Neurogenic Orthostatic Hypotension

17 Dec 2024

·www.prnewswire.com

Theravance Biopharma to Conduct Investor Meetings During the J.P. Morgan 43rd Annual Healthcare Conference

DUBLIN, Dec. 17, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that members of its management team will hold investor meetings during the 43rd Annual J.P. Morgan Healthcare Conference, January 13-16, 2025, in San Francisco, CA. To request a one-on-one meeting with the Theravance Biopharma management team, please contact us at [email protected]. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

20 Nov 2024

·www.prnewswire.com

Theravance Biopharma to Participate in an Upcoming Investor Conference

DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a Fireside Chat at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 11:15 am EST (8:15 am PST/4:15 pm GMT) and will be hosting in-person meetings with the investment community at the conference. Webcast of the event may be accessed by visiting Theravance.com, under the Investors section, Events and Presentations. Replay of the webcast will be archived on the Company's website for 30 days. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

24 Oct 2024

·www.prnewswire.com

Theravance Biopharma to Report Third Quarter 2024 Financial Results on November 12, 2024

DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will report its third quarter 2024 financial results and provide a business update after market close on Tuesday, November 12, 2024. An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm EST (2:00 pm PST/10:00 pm GMT) that day. Conference Call Information To participate in the live call by telephone, please pre-register here. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at , under the Investors section, Events and Presentations. A replay of the webcast will be available on Theravance Biopharma's website for 30 days through December 12, 2024. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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