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.
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.
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.
Parallel
Bilateral Sequential Stellate Ganglion Block
Procedure/SurgeryParticipants 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.
Completion of the Core Phase 1 Phenotyping Protocol
Percentage of enrolled participants who complete the predefined core multidomain Phase 1 phenotyping protocol.
Completeness of Phase 1 Phenotyping Data
Proportion of participants with complete and interpretable data across the predefined phenotyping domains. Data completeness will be assessed to determine the feasibility of using the multidomain assessment battery in a future randomized trial.
Progression of Patients With POTS to the Interventional Phase
Percentage of eligible patients with POTS who proceed from Phase 1 phenotyping to Phase 2 and undergo stellate ganglion block.
Completion of Both Planned Stellate Ganglion Block Procedures
Percentage of participants entering Phase 2 who complete both the right and left stellate ganglion block procedures as planned.
Technical Success of Stellate Ganglion Block
Percentage of performed stellate ganglion block procedures meeting the predefined criteria for technical success. Technical success will be based primarily on thermographic evidence of ipsilateral sympathetic blockade, supported by clinical signs where present.
Change in Orthostatic Heart Rate Increment
Change from baseline in the maximum increase in heart rate from the supine position during the orthostatic test.
Change in Mean Standing Heart Rate
Change from baseline in RMSSD derived from heart-rate variability analysis during standardized orthostatic testing.
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)
Change from baseline in SDNN derived from heart-rate variability analysis during standardized orthostatic testing.
Change in Standing Plasma Metanephrine and Normetanephrine
Change from baseline in plasma metanephrine and normetanephrine measured after 10 minutes of orthostatic test.
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