Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving...
Orthostatic IntoleranceOrthostatic HypotensionIncidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives
CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study
Neurogenic Orthostatic HypotensionAutonomic FailureNeurogenic 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 A previous study (unpublished) showed that hypercapnia significantly increases standing BP in patients with nOH.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.
A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.
Orthostatic HypotensionThe goal of this clinical trial is to test a novel medical device (ISO-101) in patients diagnosied with orthostatic hypotension. The main question[s] it aims to answer are: to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation. Assess the safety and performance of the ISO-101 device in patients with orthostatic hypotension. Participants will use the device under controlled conditions and have the following parameters measured before and after standing up: blood pressure markers of peripheal vascular resistence sympathetic nervous system activity measure before and after standing up
Advancing Understanding of Transportation Options
Diabetic RetinopathyMacular Degeneration30 moreThis Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.
Water and the Gastropressor Response - Tachyphylaxis
Orthostatic HypotensionWe are studying the effects of oral water ingestion in patients with orthostatic hypotension. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier.
Droxidopa / Pyridostigmine in Orthostatic Hypotension
Orthostatic HypotensionThis study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.
Orthostatic Hypotension in Hypertensive Patient Hospitalized in Internal Medicine
HospitalizationThe two scientific societies FADOI and SIIA have decided to start a collaborative study protocol that, through the application of a simple and homogeneous method to diagnose orthostatic hypotension, aims to estimate prevalence, conditions associates and outcomes in a cohort of patients admitted to Internal Medicine Departments and with known or newly diagnosed arterial hypertension.
Natural History Study of Synucleinopathies
Patients With SynucleinopathiesNeurogenic Orthostatic Hypotension6 moreSynucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movement, coordination difficulties or mild cognitive impairment. Development of these features indicates that abnormal alpha-synuclein deposits have destroyed key areas of the brain involved in the control of movement or cognition. Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA). However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms of autonomic impairment (unexplained constipation, urinary difficulties, and sexual dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic hypotension) may be the only clinical finding. This "pre-motor" autonomic stage suggests that the disease process may not yet have spread to the brain. After a variable period of time, but usually within 5-years, most patients with abnormally low blood pressure on standing develop cognitive or motor abnormalities. This stepwise evolution indicates that the disease spreads from the body to the brain. Another indication of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem that occurs when the lower part of the brain is affected, may also be the first noticeable sign of Parkinson disease. The purpose of this study is to document the clinical features and biological markers of patients with synucleinopathies and better understand how these disorders evolve over time. The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA) and those believed to be in the "pre-motor" stage (with isolated autonomic impairment and/or RBD). Through a careful series of follow-up visits to participating Centers, we will focus on finding biological clues that predict which patients will develop motor/cognitive problems and which ones have the resilience to keep the disease at bay preventing spread to the brain. We will also define the natural history of MSA - the most aggressive of the synucleinopathies.
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary...
Symptomatic Neurogenic Orthostatic HypotensionMSA2 moreA Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy...
Symptomatic Neurogenic Orthostatic HypotensionParkinson's Disease3 moreEvaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.