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NCT05375968 · ClinicalTrials.gov registry record · Phase 2
Splanchnic Venous Capacitance in Postural Tachycardia Syndrome
A Phase 2 study of Postural Tachycardia Syndrome (POTS), sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05375968 is a Phase 2 study of Postural Tachycardia Syndrome (POTS) that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 50 participants, roughly in line with the 46-participant average among 3 other Postural Tachycardia Syndrome (POTS) trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT05375968, a Phase 2 study of Postural Tachycardia Syndrome (POTS), is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Measurement of Splanchnic venous capacitance(SVC)done at Baseline and after 90 min of 75 g glucose in Healthy Controls POTS patients
- DIAGNOSTIC_TEST Measurement of Splanchnic venous capacitance(SVC)done at Baseline and after 90 min of 75 g glucose in Healthy Controls
- DRUG Compare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH2
- DRUG Compare change is SVC and SMA flow due to saline
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-02-25 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05375968
The ClinicalTrials.gov registry entry for NCT05375968 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 46-participant average among 3 other Postural Tachycardia Syndrome (POTS) trials with a reported enrollment target. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postural Tachycardia Syndrome (POTS) appearing as the primary indexed condition, and to 4 interventions - of which Measurement of Splanchnic venous capacitance(SVC)done at Baseline and after 90 min of 75 g glucose in Healthy Controls POTS patients is the first listed.
NCT05375968 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05375968 about?
NCT05375968 is a clinical study titled "Splanchnic Venous Capacitance in Postural Tachycardia Syndrome". 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 i...
What is the current status of trial NCT05375968?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-02-25. Estimated completion is 2028-06-01.
What conditions does trial NCT05375968 study?
This clinical trial studies the following conditions: Postural Tachycardia Syndrome (POTS).
What interventions are being tested in trial NCT05375968?
The interventions under investigation include: Measurement of Splanchnic venous capacitance(SVC)done at Baseline and after 90 min of 75 g glucose in Healthy Controls POTS patients (DIAGNOSTIC_TEST), Measurement of Splanchnic venous capacitance(SVC)done at Baseline and after 90 min of 75 g glucose in Healthy Controls (DIAGNOSTIC_TEST), Compare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH2 (DRUG), Compare change is SVC and SMA flow due to saline (DRUG).
Who is sponsoring clinical trial NCT05375968?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05375968 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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