Dietary Salt in Postural Tachycardia Syndrome
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 1/12/2019 |
Start Date: | March 2012 |
End Date: | December 2019 |
Patients with POTS may not adequately expand their plasma volume in response to a high-sodium
diet. Mechanisms involved in the regulation of plasma volume, such as the
renin-angiotensin-aldosterone system and renal DA, 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.
diet. Mechanisms involved in the regulation of plasma volume, such as the
renin-angiotensin-aldosterone system and renal DA, 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 Day 1
- Start 150 mEq Na+/day diet (POTS patients as inpatients; healthy control subjects with
CRC provided outpatient diet)
- Start a 24h urine collection (for Na+, K+, Cr, fractionated catecholamines)
- Blood work
- Blood volume - carbon monoxide rebreathing
Study Day 2
- Complete 24h urine
- Start STUDY DIET (10 mEq Na+/day or 300 mEq Na+/day in a random order) after 3 meals of
150 mEq Na+/day are complete; water ad lib
Study Day 3 - 5
- Continue STUDY DIET; water ad lib
- On Day 5, a 24 hr holter combined ECG monitor will be placed on the subjects.
Study Day 6
- Continue STUDY DIET; water ad lib
- Remove 24h Holter combined ECG monitor and BP monitor from subject
- Start a 24h urine collection (for Na+, K+, Cr, fractionated catecholamines)
- Complete questionnaires
- NPO after midnight for study next day
Study Day 7 (BIG DAY)
- Awaken early (~6am) to void (still collecting 24h urine)
- Patient returns to bed, IV catheter inserted
- Posture Study (in morning; between 7-8am ideally)
- Blood pressure and heart rate will be measured while supine and then while standing for
up to 30 minutes
- We will draw 3 tablespoons of blood in each body position to measure hormones that
regulate blood pressure and blood volume
- Hormones to verify the subject's phase of menstrual cycle
- Serum/plasma aliquots for future analysis
- Subjects will rate symptoms during supine period and at end of stand using Vanderbilt
Orthostatic Symptoms Score (VOSS)
- Total Blood Volume (DAXOR)- using injection of iodinated I-131 tagged human serum
albumin nominally 25 micro-Ci of radiation blood samples drawn through IV catheter
before injection and for ~30 minutes post-injection (total - 25 ml)
- This will be done after supine assessment, but before standing the subject up
- Autonomic Function Test with Cardiac Output and Brief Tilt
- The subject will be tilted up to 60-75 degrees head-up tilt for up to 10 minutes to
measure the changes in heart rate and blood pressure and symptoms with upright
challenge.
- Blood volume - carbon monoxide rebreathing
- Exercise Capacity Test (in the afternoon) Will estimate maximal oxygen consumption (VO2
max) This test will be conducted on a stationary bicycle. Effort will be gradually
increase while expired air is measured during exhaustive physical work.
All procedures are repeated at least a month later with the 2nd level of dietary salt.
(Randomized to high or low salt to the first phase, the second phase is the remaining level)
- Start 150 mEq Na+/day diet (POTS patients as inpatients; healthy control subjects with
CRC provided outpatient diet)
- Start a 24h urine collection (for Na+, K+, Cr, fractionated catecholamines)
- Blood work
- Blood volume - carbon monoxide rebreathing
Study Day 2
- Complete 24h urine
- Start STUDY DIET (10 mEq Na+/day or 300 mEq Na+/day in a random order) after 3 meals of
150 mEq Na+/day are complete; water ad lib
Study Day 3 - 5
- Continue STUDY DIET; water ad lib
- On Day 5, a 24 hr holter combined ECG monitor will be placed on the subjects.
Study Day 6
- Continue STUDY DIET; water ad lib
- Remove 24h Holter combined ECG monitor and BP monitor from subject
- Start a 24h urine collection (for Na+, K+, Cr, fractionated catecholamines)
- Complete questionnaires
- NPO after midnight for study next day
Study Day 7 (BIG DAY)
- Awaken early (~6am) to void (still collecting 24h urine)
- Patient returns to bed, IV catheter inserted
- Posture Study (in morning; between 7-8am ideally)
- Blood pressure and heart rate will be measured while supine and then while standing for
up to 30 minutes
- We will draw 3 tablespoons of blood in each body position to measure hormones that
regulate blood pressure and blood volume
- Hormones to verify the subject's phase of menstrual cycle
- Serum/plasma aliquots for future analysis
- Subjects will rate symptoms during supine period and at end of stand using Vanderbilt
Orthostatic Symptoms Score (VOSS)
- Total Blood Volume (DAXOR)- using injection of iodinated I-131 tagged human serum
albumin nominally 25 micro-Ci of radiation blood samples drawn through IV catheter
before injection and for ~30 minutes post-injection (total - 25 ml)
- This will be done after supine assessment, but before standing the subject up
- Autonomic Function Test with Cardiac Output and Brief Tilt
- The subject will be tilted up to 60-75 degrees head-up tilt for up to 10 minutes to
measure the changes in heart rate and blood pressure and symptoms with upright
challenge.
- Blood volume - carbon monoxide rebreathing
- Exercise Capacity Test (in the afternoon) Will estimate maximal oxygen consumption (VO2
max) This test will be conducted on a stationary bicycle. Effort will be gradually
increase while expired air is measured during exhaustive physical work.
All procedures are repeated at least a month later with the 2nd level of dietary salt.
(Randomized to high or low salt to the first phase, the second phase is the remaining level)
Inclusion Criteria:
- Diagnosed with postural tachycardia syndrome 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
- Age between 18-50 years old
- Non-smokers
- Premenopausal patients with POTS and healthy volunteers
- Only female participants are eligible.
- Since 80-90% of POTS patients are female, and there can be differences in measures
with the menstrual cycle, including a small number of males might introduce a
significant amount of noise.
- Able and willing to provide informed consent
Exclusion Criteria:
- Smokers
- Overt cause for postural tachycardia, i.e., acute dehydration
- Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or
screening results
- Pregnant (positive pregnancy test) or breastfeeding
- Hypertension defined as supine resting BP>145/95 mmHg off medications or needing
antihypertensive medication
- Other factors which in the investigator's opinion would prevent the participant from
completing the protocol, including poor compliance during previous studies or an
unpredictable schedule
- Unable to give informed consent
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-2931
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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