Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)

NCT ID: NCT01000350

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2028-06-30

Brief Summary

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The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).

Detailed Description

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Conditions

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Postural Tachycardia Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Post Saline

Saline infusion 1L hours before exercise test

Group Type EXPERIMENTAL

Saline

Intervention Type DRUG

IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study

Placebo

Placebo given prior to exercise test

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo x1 lactose tablet

Interventions

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Saline

IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study

Intervention Type DRUG

Placebo

Placebo x1 lactose tablet

Intervention Type OTHER

Other Intervention Names

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Normal Saline 0.9% saline

Eligibility Criteria

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Inclusion Criteria

* Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
* Age between 18-65 years
* Male and female are eligible (although the majority of POTS patients are female).
* Able and willing to provide informed consent

Exclusion Criteria

* Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
* Pregnancy
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
* Patients who are bedridden or chair-ridden
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Satish R. Raj

Adjunct Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Satish R Raj, MD MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Raj SR, Biaggioni I, Yamhure PC, Black BK, Paranjape SY, Byrne DW, Robertson D. Renin-aldosterone paradox and perturbed blood volume regulation underlying postural tachycardia syndrome. Circulation. 2005 Apr 5;111(13):1574-82. doi: 10.1161/01.CIR.0000160356.97313.5D. Epub 2005 Mar 21.

Reference Type BACKGROUND
PMID: 15781744 (View on PubMed)

Other Identifiers

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090942

Identifier Type: -

Identifier Source: org_study_id

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