High Sodium Diet and External Abdominal Compression in POTS

NCT ID: NCT01771484

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-01-31

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.

Detailed Description

The study will involve a crossover design in which each subject will be assessed (as below) while on a very low-sodium (10 milliequivalent/day) diet compared with a very high-sodium diet (300 milliequivalent/day). These acute dietary interventions will be part of the parent study ("Dietary Salt in Postural Tachycardia Syndrome" IRB#111261) for 4-5 days at the time of the study. Dietary success will be assessed using a 24h urine for sodium and creatinine as a part of the parent study.

Study Day:

• Studies will be performed at the end of the low and high-sodium diet phases.
• Blood pressure recording will not begin until at least 2 hours after the last meal (to avoid any confounding hypotension from the last meal).
• Subject will be asked to void prior to data collection.
• The subject will be seated in a chair, with their feet comfortably on the floor.
• The Dinamap electrocardiographic and blood pressure (brachial cuff) recorder will be attached to the patient and set up for measurements every 10 minutes throughout the study with digital download into the Autonomic Dysfunction Center BP database.
• After a 20-minute seated baseline, the subject will stand for up to10 minutes. Heart rate and blood pressure (HR/BP) will be measured at 1, 3, 5, and 10 minutes of standing. At the end of the baseline stand period, subjects will be asked to rate their symptoms using the provided orthostatic intolerance Symptoms questionnaire.
• The subject will then be seated and the abdominal binder will be applied without compression.
• The Dinamap electrocardiographic and blood pressure (brachial cuff) recorder will be attached to the patient and set up for measurements every 10 minutes throughout the study with digital download into the Autonomic Dysfunction Center BP database.
• At 1 and 2 hours post intervention, the subject will be asked to stand for up to 10 minutes while applying external automated abdominal binder compression (up to 40 mmHg). HR/BP will be measured at 1, 3, 5, and 10 minutes of standing.

o If nursing staffing shortages make q1h standing difficult, then the subject should be asked to stand at least at 2 hours post intervention.

• Study termination for that day.

Conditions

Postural Orthostatic Tachycardia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Low Sodium Diet

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

Group Type: EXPERIMENTAL

External automated abdominal binder

Intervention Type: 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

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

Group Type: EXPERIMENTAL

External automated abdominal binder

Intervention Type: 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.

Interventions

External automated abdominal binder

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Italo Biaggioni

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Italo Biaggioni, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

121178

Identifier Type: -

Identifier Source: org_study_id