NCT05375968 Splanchnic Venous Capacitance in Postural Tachycardia Syndrome
| NCT ID | NCT05375968 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Postural Tachycardia Syndrome (POTS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-02-25 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2023-02-25 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Postural tachycardia syndrome (POTS) affects ≈3 million young people, characterized by chronic presyncopal symptoms characterized by dizziness, lightheadedness, and orthostatic tachycardia that occur while standing. Across-sectional survey found that 25% of these patients complains that meals rich in carbohydrates are among the factors that further exacerbate POTS's symptoms and cause a myriad of gastrointestinal symptoms. The splanchnic circulation is the largest blood volume reservoir of the human body, storing ≈25% of the total blood volume and contributing to sudden, and large, fluctuations in the stroke volume (SV). The orthostatic changes in systemic hemodynamics are particularly magnified after meals, due to increased blood volume sequestration triggered by the release of gastrointestinal peptides with vasodilatory properties. The purpose of this study is to determine if the worsening orthostatic tachycardia and symptoms after glucose ingestion in POTS patients are due to a greater increase in splanchnic venous capacitance and excessive blood pooling on standing as compare to Healthy controls. The study will also determine if glucose-induced GIP secretion increases splanchnic venous capacitance, orthostatic tachycardia and worsening POTS postprandial symptoms. For this purpose subjects will be further randomized to either saline versus GIP(3-30)NH2 acute infusion, to measure the changes their splanchnic venous capacitance and superior mesenteric arterial flow before and after a 75-g oral glucose challenge during supine and 45-degree head-up tilt positions (orthostatic challenge) for up to 3 hours.
Eligibility Criteria
Inclusion Criteria: * Between 18 and 50years of age * Cases: Diagnosis of POTS with presyncope symptoms after meals Or Controls: * With no significant past medical history, non-smokers and not on chronic medications. * Body mass index (BMI) between 18.5 to 29.9 kg/m2 * If pre-menopausal women: must have regular menstrual cycle. Exclusion Criteria: * BMI above ≥30 kg/m2 * Irregular menstrual cycle * Intolerance to CPAP. * Chronic use of acetaminophen * Heart problems: myocardial infarction, angina, heart failure, stroke * Undergone any heart related procedures or stents or on pacemaker. * Uncontrolled hypertension. * Type 1 or type 2 diabetes mellitus * Pregnant or breast-feeding women. * Impaired liver function * Impaired Kidney function test. * Anemia (Hematocrit\<34%). * Ongoing substance abuse. * Subjects with abnormal EKG * History of seizures. * Diagnosed with neuropathy due to any reason * History of neck surgery. * Smoker, * On statin therapy for high cholesterol * Rheumatoid arthritis. * On oral corticosteroids, * Current infections * Documented of moderate decrease in blood volume
Contact & Investigator
Cyndya Shibao, M.D
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT05375968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Postural Tachycardia Syndrome (POTS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05375968 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05375968 currently recruiting?
Yes, NCT05375968 is actively recruiting participants. Contact the research team at pedro.ortiz.saavedra@vumc.org for enrollment information.
Where is the NCT05375968 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05375968 clinical trial?
NCT05375968 is sponsored by Vanderbilt University Medical Center. The principal investigator is Cyndya Shibao, M.D at Vanderbilt University Medical Center. The trial plans to enroll 50 participants.