CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Blood Volume +3 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01547117
NCT01547117N/ACompleted

Dietary Salt in Postural Tachycardia Syndrome

Vanderbilt University·interventional·Posted Mar 7, 2012·Updated Feb 22, 2022

In Brief

A clinical study evaluating Blood Volume, Total Blood Volume, and 2 other interventions for Postural Orthostatic Tachycardia Syndrome. Completed, enrolled 38 participants across 1 site.

Detailed Summary

Patients with POTS may not adequately expand their plasma volume in response to a high-sodium (Na+) diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine, may be impaired in POTS and may respond inappropriately to changes in dietary sodium.The purpose of this study is to determine (1) whether a high dietary sodium level appropriately expands plasma volume in POTS; (2) whether plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium in POTS; and (3) whether patients with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2012
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2020
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 14.3 years ago

Interventions

Blood Volumeradiation

we will measure the amount of hemoglobin and myoglobin in the body by a procedure called CO rebreathing. One teaspoon of blood is taken before and after a small amount of CO has been absorbed into the bloodstream.

Total Blood Volumeradiation

Using injection of iodinated I-131 tagged human serum albumin nominally 25 microcuries of radiation, blood samples are drawn before and 30 minutes after injection.

Exercise Capacity Test - Bicycleprocedure

subjects breath room air through a mouthpiece and exhale the air into a tube that connects to a machine (metabolic cart) that analyzes carbon dioxide and oxygen content, which allows the investigator to calculate the amount of oxygen they are using under resting and exercise conditions.

Posture Studyprocedure

Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume.