High Sodium Diet and External Abdominal Compression in POTS

NCT01771484 | Terminated Phase 1 DMC

• 1 other identifier: 121178
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test to determine if an external Automated Abdominal Binder (non-commercial product) during high sodium diet improves orthostatic tolerance, compared to wearing the binder during a low sodium diet session.

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

tachycardia; pots; orthostatic intolerance

Outcome Measures

Primary Outcomes (1)

• Change from baseline in orthostatic tachycardia

  The primary end point is the change from baseline in orthostatic heart rate (change in HR on standing from a seated position) 2 hrs after baseline.

  2 hours post baseline

Secondary Outcomes (1)

• Change from baseline in orthostatic symptoms

  2 hours post baseline

Study Arms (2)

Low Sodium Diet

EXPERIMENTAL

participants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day.

Device: External automated abdominal binder

High sodium diet

EXPERIMENTAL

Participants will consume a diet high in sodium (300 milliequivalent Na+/day) for 4-5 days prior to study intervention.

Device: External automated abdominal binder

Interventions

External automated abdominal binder DEVICE

Participants will wear the abdominal compression binder on day 4 or 5 of the study diet. Seated and standing vitals will be collected before and during application of binder.

High sodium diet; Low Sodium Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postural Tachycardia Syndrome: Diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center
• Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes)
• Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
• Participation in the parent study "Dietary Salt in Postural Tachycardia Syndrome" (IRB#111261)
• Age between 18-60 years
• Male and females
• Able and willing to provide informed consent

You may not qualify if:

• Overt cause for postural tachycardia (such as acute dehydration)
• Inability to give, or withdrawal of, informed consent
• Pregnancy
• Other factors which in the investigator's opinion would prevent the subject from completing the protocol.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Tachycardia; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 18, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)