Actively Recruiting

Phase 2
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT05375968

Splanchnic Venous Capacitance in Postural Tachycardia Syndrome

Led by Vanderbilt University Medical Center · Updated on 2025-12-05

50

Participants Needed

1

Research Sites

274 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Splanchnic Venous Capacitance in Postural Tachycardia Syndrome

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 50 years of age
  • Diagnosis of POTS with presyncope symptoms after meals (for cases)
  • No significant past medical history, non-smokers, and not on chronic medications (for controls)
  • Body mass index (BMI) between 18.5 to 29.9 kg/m2
  • If pre-menopausal women, must have regular menstrual cycle
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) of 30 kg/m2 or higher
  • Irregular menstrual cycle
  • Intolerance to continuous positive airway pressure (CPAP)
  • Chronic use of acetaminophen
  • Heart problems including myocardial infarction, angina, heart failure, stroke
  • History of heart procedures, stents, or pacemaker
  • Uncontrolled hypertension
  • Type 1 or type 2 diabetes mellitus
  • Pregnant or breastfeeding women
  • Impaired liver or kidney function
  • Anemia with hematocrit less than 34%
  • Ongoing substance abuse
  • Abnormal EKG
  • History of seizures
  • Diagnosed neuropathy
  • History of neck surgery
  • Smoking
  • On statin therapy for high cholesterol
  • Rheumatoid arthritis
  • Using oral corticosteroids
  • Current infections
  • Documented moderate decrease in blood volume

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

P

Pedro J Ortiz, MD

CONTACT

M

Meena Golchha, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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