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NCT07837804

RESET-POTS: Multimodal Phenotyping and Stellate Ganglion Block in Postural Orthostatic Tachycardia Syndrome

Sponsor: University Medical Centre Ljubljana

View on ClinicalTrials.gov

Summary

RESET-POTS is a pilot study for adults with postural orthostatic tachycardia syndrome (POTS), a condition that can cause a rapid increase in heart rate, dizziness, weakness, fatigue and other symptoms when standing. The study has two parts. In the first part, patients with POTS and healthy volunteers will undergo several tests to better understand how POTS affects heart rate and blood pressure, the autonomic nervous system, hormones, metabolism, blood sugar regulation, brain and muscle oxygenation, and quality of life. In the second part, eligible patients with POTS will receive a stellate ganglion block, a procedure in which a local anaesthetic is injected near nerves in the neck that are involved in sympathetic nervous system activity. The procedure will be performed on the right and left sides on separate days. Participants will then be reassessed about 2 weeks and 3 months later. The main goals are to determine whether the study procedures are practical and well tolerated, whether the nerve block can be performed successfully and safely, and whether there are signs of changes in POTS-related body functions and symptoms.

Official title: RESET-POTS: Protocol for a Two-phase Pilot and Feasibility Study of Multidomain Phenotyping and Bilateral Sequential Stellate Ganglion Block in Postural Orthostatic Tachycardia Syndrome

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2027-12

Last Updated

2026-09-24

Healthy Volunteers

Yes

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Interventions

PROCEDURE

Bilateral Sequential Stellate Ganglion Block

Participants will undergo ultrasound-guided stellate ganglion block (SGB) on both sides, performed as two separate procedures 3-7 days apart. The right side will be treated first, followed by the left side. Each block will be performed under real-time ultrasound guidance, primarily at the C6 level, using levobupivacaine 0.5% (8 mL per side), without exceeding the recommended maximum dose. Participants will be monitored during and after each procedure. Technical success of the block will be assessed using infrared thermography and supportive clinical signs of sympathetic blockade.

Inclusion criteria: Participants with POTS: * Age 18 to 65 years. * Confirmed diagnosis of postural orthostatic tachycardia syndrome (POTS) by a cardiologist or neurologist within the previous 3 years. * Persistent symptoms of orthostatic intolerance despite or regardless of current medication use. * Ability to understand the study procedures and provide written informed consent. Healthy control participants: * Age 18 to 65 years. * Where feasible, matched to the POTS group according to age, sex, and body mass index category and, in premenopausal women, menstrual-cycle phase. * No known chronic disease. * No regular use of medication that could substantially affect autonomic, endocrine, or metabolic measurements. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria For all participants: * Pregnancy or breastfeeding. * Active acute infection at the time of assessment. * Significant comorbidity that could confound interpretation of study findings or increase procedural risk, including: type 1 or type 2 diabetes mellitus; heart failure; significant valvular heart disease; clinically relevant renal impairment; clinically relevant hepatic impairment; peripheral neuropathy; known central nervous system disease. * Contraindication to any study procedure. * An identified alternative explanation for orthostatic symptoms or tachycardia, including significant anemia, dehydration or hypovolemia, acute febrile illness or infection, hyperthyroidism, primary adrenal disease, a primary anxiety or panic disorder considered to be the principal cause of symptoms, or medication-induced tachycardia. Additional exclusion criteria for the stellate ganglion block phase: * Previous stellate ganglion block. * Known allergy or hypersensitivity to amide local anesthetics. * Current therapeutic anticoagulation or known bleeding disorder. * History of glaucoma. * Local infection or relevant anatomical abnormality at the planned injection site. * Any clinical condition considered by the investigator or anesthesiologist to make stellate ganglion block unsafe.