Autoimmune Basis for Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome · Postural Tachycardia Syndrome · Tachycardia · Arrhythmias, Cardiac · Autonomic Nervous System Diseases · Orthostatic Intolerance · Cardiovascular Diseases · Primary Dysautonomias
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 50 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 58 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The purpose of this study is to see if some people with postural tachycardia syndrome (POTS) have higher levels of immune proteins (autoantibodies) directed against receptors of the autonomic nervous system, and if these autoantibodies make a difference in their POTS symptoms. The investigators also want to see if the levels of these autoantibodies stay the same over time.
Leer la descripción completa
Postural tachycardia syndrome (POTS) is a debilitating disorder resulting from cardiovascular autonomic dysfunction, has many causes and is very difficult to treat effectively. The investigators have identified the presence of autoantibodies (immune proteins) directed against some receptors of the autonomic nervous system that can cause patient's symptoms on standing.
The present study is designed to test the hypothesis that patients with POTS harbor functional autoantibodies to adrenergic receptors that lead to an excessive tachycardia characteristic of POTS. For this purpose, this study will define the prevalence, burden, and the in vivo physiological significance of these adrenergic antibodies in a well-phenotyped and representative cohort of patients with POTS and a matched cohort of healthy control subjects, and will characterize the stability of these autoantibodies over time in affected POTS patients.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- 18-50 years old
- Postural Tachycardia Syndrome: Heart rate increase \>30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (\>20/10 mmHg fall in blood pressure), with chronic symptoms (\> 6 months), and in the absence of other acute cause of orthostatic tachycardia.
- Able and willing to provide informed consent
- Female premenopausal subjects must utilize adequate birth control and willingness to undergo serum beta-hCG testing
- The subject must understand and be able to comply with the study procedures and restrictions.
Exclusion Criteria:
- Hypertension (\>150 mmHg systolic and \>100 mmHg diastolic) based on history or findings at screening.
- Orthostatic hypotension (consistent drop in blood pressure \>20/10 mmHg with 10 min stand)
- Pregnancy
- Cardiovascular disease, such as myocardial infarction within 6 months, angina pectoris, significant arrhythmia (sinus tachycardia is not excluded), deep vein thrombosis, pulmonary embolism
- History of serious neurologic disease
- History or presence of significant immunological or hematological disorders
- Clinically significant gastrointestinal impairment that could interfere with dietary compliance or drug absorption
- Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase \>1.5 x upper limit of normal range)
- Impaired renal function (serum creatinine \>1.5 mg/dL)
- Hematocrit \<28%
- Current or concurrent disease that could affect the absorption, action or disposition of the drug, or clinical or laboratory assessments.
- Any underlying or acute disease requiring regular medication that could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- Inability to comply with the protocol
Healthy control subjects will be healthy, non-smoking and on no chronic medications at the time of the study. Healthy control subjects will be group-matched to the POTS patients for age and gender. We will attempt to study female patients in the first half of their menstrual cycle to minimize cyclical variability.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Autonomic and Antibody Assessments
On up to 3 study days, POTS patients and control subjects will have several tests to assess autonomic function and to detect the presence of autoantibodies to adrenergic receptors. The following tests will de done but in some participants it may not be necessary to do all of them. The investigator will discuss with each participant which particular tests will be done in each particular case:
- Posture study with blood samples for autoantibody testing
- 24-hour heart rhythm and blood pressure monitoring
- autonomic function tests
- Quantitative Axonal Sudomotor Reflex Testing
- Total blood volume assessment
- Pharmacologic testing with phenylephrine
- Pharmacologic testing with isoproterenol
- Cardiac output with rebreathing
- Assessment of splanchnic capacitance
- Microneurography
Drug: phenylephrine · Drug: isoproterenol · Radiation: 25 micro-Ci of radiation · Procedure: Posture study with blood samples · Procedure: 24-hour heart rhythm and blood pressure monitoring · Procedure: Quantitative Axonal Sudomotor Reflex Testing · Procedure: Autonomic function tests · Other: Rebreathing test · Other: Assessment of splanchnic capacitance · Procedure: microneurography
phenylephrine DRUG
Phenylephrine is a selective α1-adrenergic receptor agonist. It will be given in IV bolus injections starting from 12.5 ug. Incremental doses will be given every \~3 min up to 800 ug or until systolic blood pressure increases by 25 mmHg
isoproterenol DRUG
Isoproterenol is non-selective beta-adrenergic agonist. It will be given in IV bolus injections starting from 0.025 ug. Incremental doses will be given every \~3 min until heart rate increases by 25 bpm. This intervention is optional.
25 micro-Ci of radiation RADIATION
Using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation, blood samples are drawn before and 30 minutes after injection.
Posture study with blood samples PROCEDURE
Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume. An additional sample will be collected in the supine position for the autoantibody assessment.
24-hour heart rhythm and blood pressure monitoring PROCEDURE
Blood pressure, heart rate and ECG monitoring for 24 hours
Quantitative Axonal Sudomotor Reflex Testing PROCEDURE
The QSART assesses the ability of sympathetic nerve terminals in the skin to release acetylcholine and increase sweat production. The test is performed at 4 sites over the forearm, proximal lateral leg, medial distal leg and proximal foot.
Autonomic function tests PROCEDURE
The autonomic function tests will determine how well the autonomic nervous system regulates blood pressure and heart rate. These tests include breathing deeply for two minutes, breathing fast for 30 seconds, maintaining a handgrip for 3 minutes, breathing against pressure for 15 seconds, and placing the hand in ice water for 1 minute. In addition, participants will be tilted up on a tilt table for up to 10 minutes while recording their heart rate, blood pressure and cardiac output.
Rebreathing test OTHER
Cardiac output will be measured using the rebreathing technique (Innocor)
Assessment of splanchnic capacitance OTHER
Splanchnic capacitance will be assessed using cpap and body impedance to construct pressure volume curves
microneurography PROCEDURE
microneurography will be measured in the peroneal nerve to assess sympathetic activity.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Autoantibody levels
Plazo: up to 10 minutes
Blood samples collected while supine during the posture study will be analyzed for autoantibody positivity in POTS patients and control subjects.
Blood pressure after phenylephrine boluses
Plazo: 1-2 minutes after bolus injections
No informado en este registro.
Heart rate after isoproterenol boluses
Plazo: 1-2 minutes after bolus injections
No informado en este registro.
Orthostatic change in heart rate
Plazo: up to 10 minutes
Difference between standing and supine heart rates.
Medidas secundarias
Blood pressure response during phase IV of the Valsalva maneuver
Plazo: up to 10 minutes
No informado en este registro.
Hear rate response during phase IV of the Valsalva maneuver
Plazo: up to 10 minutes
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (2)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
2 centros
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma, United StatesEstado desconocido
Autonomic Dysfunction CenterNashville, Tennessee, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Vanderbilt University Medical Center
- Inicio del estudio
- 2016-02 Real
- Finalización primaria
- 2027-02 Estimado
- Finalización del estudio
- 2027-06 Estimado
- Primera publicación
- 31 mar 2016 Estimado
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Autoimmune Basis for Postural Tachycardia Syndrome
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026