[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurogenic-orthostatic-hypotension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurogenic-orthostatic-hypotension":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,70,94,114,142],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100193894","natural-history-study-of-synucleinopathies-100193894",false,"NCT01799915","Natural History Study of Synucleinopathies","Inclusion Criteria:\n\n1. Both male and female patients will be included\n2. Aged 18 or over\n3. Referred to any of the participating consortium sites with orthostatic intolerance, defined as symptoms of dizziness or lightheadedness in the standing position that disappear when supine.\n\nExclusion Criteria:\n\n1. Diabetes according to the American Diabetes Association criteria\n2. Congestive heart failure\n3. Lupus or other collagen vascular disease\n4. Systemic illness thought to be responsible for the orthostatic intolerance\n5. Drug-induced orthostatic hypotension (i.e., the use of alpha-blockers, diuretics, tricyclic antidepressants or others thought by the investigator to play an important role in the patient's orthostatic hypotension)\n6. Isolated vasovagal syncope\n7. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.","ALL","18 Years",{"count":18,"type":19},800,"ESTIMATED","OBSERVATIONAL","Synucleinopathies 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).\n\nHowever, 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.\n\nAfter 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.\n\nThe 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\u002FDLB and MSA) and those believed to be in the \"pre-motor\" stage (with isolated autonomic impairment and\u002For 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\u002Fcognitive 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.",[23,24,25,26,27,28,29,30],"Patients With Synucleinopathies","Neurogenic Orthostatic Hypotension","Pure Autonomic Failure","REM Sleep Behavior Disorder","Parkinson Disease","Dementia With Lewy Bodies","Multiple System Atrophy","Shy-Drager Disease","RECRUITING","2026-06-09",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":35},"2011-06",{"date":39,"type":19},"2026-12-30",{"name":41,"class":42},"NYU Langone Health","OTHER",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100599788","phase-2-a-study-in-subjects-with-neurogenic-orthostatic-hypotension-100599788","NCT07089043","A Study in Subjects With Neurogenic Orthostatic Hypotension","A Single-Blind Dose-Ranging Study in Subjects With Neurogenic Orthostatic Hypotension to Evaluate the Effect of CST-3056 on Symptoms and Signs of Orthostatic Hypotension","Inclusion Criteria:\n\n1. Male or female subjects ≥ 18 and ≤ 85 years of age, at time of informed consent.\n2. Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease or pure autonomic failure (i.e. neurogenic orthostatic hypotension).\n3. At Screening, subjects must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a decrease ≥20 mm Hg in systolic or ≥10 mm Hg in diastolic BP upon standing ≤3 minutes from a supine position.\n4. At Screening, subjects must have a score ≥4 on the Orthostatic Hypotension Symptom Assessment (OHSA) scale question #1.\n5. Currently receiving, or known to be responsive to, direct or indirect α1-AR agonists (e.g., midodrine, droxidopa) for treatment of nOH.\n6. If the Investigator determines that additional autonomic function testing is required to confirm the diagnosis of autonomic dysfunction, the Valsalva maneuver may be performed to show the absence of BP overshoot during phase IV.\n7. Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg\u002Fm2, inclusive at Screening.\n8. Stable medical conditions for 3 months prior to Screening.\n9. For patients taking antiparkinsonian medication: stable dose of levodopa, dopamine agonist, amantadine, and\u002For monoamine oxidase B inhibitor, i.e. unchanged for 1 month.\n10. Subject is ambulatory with\u002Fwithout the use of an assistive device.\n11. Willing to follow the protocol requirements and comply with protocol restrictions.\n12. Capable of providing informed consent and complying with study procedures.\n13. Able to speak, understand, and read English.\n\nExclusion Criteria:\n\n1. Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.\n2. Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure (BP) such as ephedrine, dihydroergotamine, or midodrine must be stopped at least 1 day or 5 half-lives (whichever is longer) prior to dosing on Day 1 and throughout the duration of the study. Fludrocortisone use in the study will be limited to a stable dose of 0.1 mg once-daily (QD).\n3. Supine SBP ≥ 170 mm Hg or seated SBP ≥ 140 mm Hg at Screening.\n4. Subjects with clinically meaningful urinary retention who use or are likely to use α1-AR antagonists (e.g., tamsulosin \\[Flomax\\]), or other medications (e.g., trazodone).\n5. Concomitant use of anti-hypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.\n6. Evidence of any significant or unstable clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine (excluding managed hypo and hyperthyroidism), metabolic, renal, or other systemic disease or laboratory abnormality.\n7. History of malignant disease within 5 years, including solid tumors and hematologic malignancies (except \\[a\\] basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured; \\[b\\] low-grade adenocarcinoma of the prostate).\n8. Any clinically significant illness or disease (apart from those typically associated with neurodegenerative disease) as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted at Screening.\n9. History of suicidal ideation or an episode of clinically severe depression as determined by the Investigator.\n10. Clinically significant abnormalities of ECG, including QTcF \\> 450 ms, for males and QTcF \\> 470 ms for females, and\u002For HR \\\u003C 50 beats per minute, or evidence of clinically significant bundle branch blocks, as indicated by 12-lead ECG in a supine position at Screening.\n11. A calculated eGFR of ≤60 mL\u002Fmin\u002F1.73m2 according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation at Screening.\n12. Current use of any prohibited prescription medication during Screening or throughout study, unless approved by both the Investigator and the Sponsor Medical Monitor.\n13. Prior treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrollment in any other study treatment or disease study, except for observational studies.\n14. Known or suspected alcohol or substance abuse within the past 12 months and\u002For positive test for alcohol or drugs of abuse at Screening.\n15. Positive screening test for human immunodeficiency virus (HIV), hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen \\[HbsAg\\] at Screening).\n16. Females who are breastfeeding.\n17. Any other reason for which the Investigator considers it is not in the best interest of the subject to undertake the study.","85 Years",{"count":53,"type":19},12,"INTERVENTIONAL",[56],"PHASE2","This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).",[24],"2026-05-01",{"date":61,"type":35},"2026-05-05",{"date":63,"type":35},"2025-09-12",{"date":65,"type":19},"2026-06-30",{"name":67,"class":68},"CuraSen Therapeutics, Inc.","INDUSTRY",5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":54,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100509079","co2-rebreathing-in-noh-a-proof-of-concept-pilot-study-100509079","NCT05908760","CO2 Rebreathing in nOH: A Proof-of-Concept Pilot Study","CO2 Rebreathing to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: A Proof-of-Concept Pilot Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Male and Female\n* Physician diagnosis of Neurogenic Orthostatic Hypotension\n* Non-smokers.\n* Able and willing to provide informed consent.\n* Ability to travel to Libin Cardiovascular Institute Autonomic Testing Lab at the University of Calgary, Calgary, AB.\n\nExclusion Criteria:\n\n* Medical therapies or medications which could interfere with testing of autonomic function\n* Pregnant or breast-feeding females\n* Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath.\n* 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\u002For drug abuse, cerebrovascular disease, kidney or liver disease, surgical procedures where the nerves of the sympathetic nervous system have been cut.\n* Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.","100 Years",{"count":79,"type":19},28,[81],"NA","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\u002F10mmHg, 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.\n\nThis 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.\n\nMale 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.\n\nThe 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.",[24,84],"Autonomic Failure","2026-04-29",{"date":61,"type":35},{"date":88,"type":35},"2024-07-30",{"date":90,"type":19},"2030-12-31",{"name":92,"class":42},"University of Calgary",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":15,"minAge":16,"maxAge":77,"enrollmentInfo":102,"targetDuration":4,"studyType":54,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":93},"100461988","hypercapnia-in-orthostatic-hypotension-100461988","NCT05295810","Hypercapnia in Orthostatic Hypotension","Investigating Hypercapnia to Treat Neurogenic Orthostatic Hypotension","Inclusion Criteria:\n\n* Age ≥18 years\n* Male and Female\n* Non - smokers.\n* Able and willing to provide informed consent.\n* Ability to travel to Libin Cardiovascular Institute Autonomic Testing Lab at the University of Calgary, Calgary, AB.\n\nExclusion Criteria:\n\n* Medical therapies or medications which could interfere with testing of autonomic function\n* Participants with somatization or severe anxiety symptoms will be excluded\n* Pregnant or breast-feeding females\n* Inability to tolerate mask for the duration of the study\n* Subjects who require portable oxygen at rest or with exercise\n* Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath.\n* 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\u002For drug abuse, cerebrovascular disease, kidney or liver disease, surgical procedures where the nerves of the sympathetic nervous system have been cut.\n* Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.",true,{"count":103,"type":19},80,[81],"The Autonomic (or \"automatic\") Nervous System (ANS) regulates internal processes, including control of heart rate and blood pressure (BP). When someone stands, and gravity tries to pull blood away from the brain, the ANS works to maintain BP and brain blood flow. Neurogenic Orthostatic Hypotension (NOH) occurs when our \"fight-or-flight\" part (\"sympathetic\") of the ANS fails. BP can drop a lot when upright, reducing blood flow and oxygen delivery to the brain, and this can cause symptoms of light-headedness, nausea, and fainting.\n\nOne solution to help counter the effects of NOH may be to increase sympathetic activity by breathing higher levels of carbon dioxide. In healthy volunteers, small increases in the amount of inhaled carbon dioxide has been shown to increase BP in the upright position, and this improves symptoms!\n\nThe objectives of the current study are to apply carbon dioxide in patients with NOH and healthy controls to: (a) evaluate the effects of breathing carbon dioxide on BP and brain blood flow, and (b) determine if a device that increases carbon dioxide while standing will work as a new therapy",[107,24],"Orthostatic Hypotension",{"date":61,"type":35},{"date":110,"type":35},"2022-03-01",{"date":112,"type":19},"2030-05-31",{"name":92,"class":42},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":15,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":54,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":93},"100476871","cpap-for-the-treatment-of-supine-hypertension-100476871","NCT05489575","CPAP for the Treatment of Supine Hypertension","Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension","Inclusion Criteria:\n\n* Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.\n* Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.\n* Nocturnal supine hypertension (nighttime systolic blood pressure ≥140 mmHg) during the overnight screening for supine hypertension.\n* Patients who are willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Patients with history of recent facial trauma or surgery or intolerance to CPAP or to the CPAP mask.\n* Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute or those with sustained supine blood pressure ≥180\u002F110 mmHg after the medication withdrawal period.\n* Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.\n* Smokers, patients who are pregnant, or have clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months; heart failure; and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical or laboratory testing.","40 Years","80 Years",{"count":124,"type":19},59,[81],"This study aims to learn about the effects of continuous positive airway pressure (CPAP) on people with autonomic failure and high blood pressure when lying down (supine hypertension) to determine if it can be used to treat their high blood pressure during the night. CPAP (a widely used treatment for sleep apnea) involves using a machine that blows air into a tube connected to a mask covering the nose, or nose and mouth, to apply a low air pressure in the airways.\n\nThe study includes 3-5 days spent in the Vanderbilt Clinical Research Center (CRC): at least one day of screening tests, followed by up to 3 study days. Subjects may be able to participate in daytime and\u002For overnight studies. The Daytime study consists of 2 study days: one with active CPAP and one with sham CPAP applied for up to 2 hours. The Overnight study consists of 3 study nights: one with active CPAP, one with sham CPAP, both applied for up to 9 hours and one night sleeping with the bed tilted head-up.",[84,25,29,27,128,24],"Supine Hypertension",[130,131,132],"CPAP","Hypertension","Orthostatic hypotension","2026-03-31",{"date":135,"type":35},"2026-04-07",{"date":137,"type":35},"2022-06-23",{"date":139,"type":19},"2027-08-31",{"name":141,"class":42},"Vanderbilt University Medical Center",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":54,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":93},"100573869","controlled-co2-inhalation-in-noh-100573869","NCT06751888","Controlled CO2 Inhalation in NOH","Controlled CO2 Inhalation to Increase Blood Pressure in Neurogenic Orthostatic Hypotension: a Proof-of-Concept Novel Therapy Study","CO2-nOH","Inclusion Criteria:\n\n* Age ≥18 years\n* Male and Female\n* Physician diagnosis of Neurogenic Orthostatic Hypotension\n* Non-smokers.\n* Able and willing to provide informed consent.\n* Ability to travel to Libin Cardiovascular Institute Autonomic Testing Lab at the University of Calgary, Calgary, AB.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding females\n* Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath.\n* 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\u002For drug abuse.\n* Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.",{"count":79,"type":19},[81],"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.",[24],[24,155,156,157,158,159,160],"Autonomic","Cardiovascular","Therapies","Quality-of-life","Symptom-management","Novel","NOT_YET_RECRUITING","2024-12-20",{"date":164,"type":35},"2024-12-30",{"date":166,"type":19},"2025-05-01",{"date":168,"type":19},"2028-12-31",{"name":92,"class":42}]