Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924646
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-06-20
Brief Title:
CAlgary SAlt for POTS
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
CAlgary SAlt for Postural Orthostatic Tachycardia Syndrome Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASA-POTS
Brief Summary:
Many patients with postural orthostatic tachycardia syndrome POTS have decreased plasma volume Current POTS guidelines recommend 10 g of salt and 2-3 L of fluid per day Despite this recommendation there is no long term data evaluating the use of salt in POTS This randomized placebo-controlled cross-over trial will evaluate a high salt diet compared to a normal salt diet over a period of 3 months Participants will complete 3 in lab evaluations including autonomic function testing tilt table testing blood volume and urine sodium evaluation plasma catecholamine measurements and and cytokine measurements
Detailed Description:
Background and Rationale
Postural Orthostatic Tachycardia Syndrome POTS is a form of autonomic cardiovascular disease primarily in women that is often disabling The investigators and others have found that many patients with postural tachycardia have decreased plasma volume Current POTS guidelines recommend 10 g of salt and 2-3 L of fluid per day In a proof of concept dietary salt study the investigators recently showed 6 days of a high salt diet 300 mEqd compared to a low salt diet increases plasma volume reduced standing plasma norepinephrine and reduced HR The high salt diet reduced the median orthostatic tachycardia by 14 bpm Currently there is only evidence showing the benefits of supplemental salt-intake over one week It is unknown whether the increased blood volume from high dietary salt intake will persist over several weeks or if an escape mechanism will reduce blood volumes back to baseline levels This longer-term clinical trial of high dietary salt and water will address this escape mechanism and ongoing dietary compliance in POTS
Research Question Objectives
Primary Hypothesis The primary hypothesis is that after 6 weeks of a moderate dietary salt plus additional salt diet the upright HR will be lower than after 6 weeks on a moderate dietary salt alone diet
Secondary hypotheses The secondary hypotheses include
Symptoms evaluated using the VOSS symptom score after 6 weeks of a moderate dietary salt plus additional salt diet will be reduced compared to after 6 weeks of a moderate dietary salt alone diet
Upright stroke volume after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
Blood volume after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
Upright plasma catecholamines after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
Quality of life after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
3 Methods Interventions All participants will be instructed to each 5-6 g of salt per day in their diet In the moderate dietary salt plus additional salt arm participants will receive blinded capsules that contain 6g of salt per day 12x 500g slow- release capsules They will take 2g of salt 3 times per day Participants in the placebo arm will receive blinded capsules that contain 6g of microcrystalline cellulose Protocol compliance will be assessed with 24h urine sodium
Randomization This is a blinded cross-over study The investigators will randomize patients to start with either salt capsules or placebo After the 6-week study arm participants will cross-over to the second study arm
Study Visit Schedule The study will consist of three in-house study sessions a baseline assessment and an assessment at the end of each study arm moderate dietary salt plus additional salt and placebo The baseline visit will serve as a screening visit Each study session will take place over 1 day in the Autonomic Lab at the University of Calgary There will also be four 24hr urine sodium collections and multiple online REDCap surveys
In-Lab Evaluation The in-lab evaluation sessions while consist of autonomic function testing including a 10-minute tilt test blood volume assessment and supine and standing bloodwork An IV will be started for the blood work
Urine Sodium Participants will complete a 24-hr urine sodium test around the time of each in-lab evaluation as well as before the 1 week study wash in
Study Surveys At each assessment point baseline and end of each arm the investigators will send participants a secure REDCap survey link At the end of the study participants will also receive a patient experience survey Participants will receive a total of 4 surveys
Postural Orthostatic Tachycardia Syndrome POTS is a form of autonomic cardiovascular disease primarily in women that is often disabling The investigators and others have found that many patients with postural tachycardia have decreased plasma volume Current POTS guidelines recommend 10 g of salt and 2-3 L of fluid per day In a proof of concept dietary salt study the investigators recently showed 6 days of a high salt diet 300 mEqd compared to a low salt diet increases plasma volume reduced standing plasma norepinephrine and reduced HR The high salt diet reduced the median orthostatic tachycardia by 14 bpm Currently there is only evidence showing the benefits of supplemental salt-intake over one week It is unknown whether the increased blood volume from high dietary salt intake will persist over several weeks or if an escape mechanism will reduce blood volumes back to baseline levels This longer-term clinical trial of high dietary salt and water will address this escape mechanism and ongoing dietary compliance in POTS
Research Question Objectives
Primary Hypothesis The primary hypothesis is that after 6 weeks of a moderate dietary salt plus additional salt diet the upright HR will be lower than after 6 weeks on a moderate dietary salt alone diet
Secondary hypotheses The secondary hypotheses include
Symptoms evaluated using the VOSS symptom score after 6 weeks of a moderate dietary salt plus additional salt diet will be reduced compared to after 6 weeks of a moderate dietary salt alone diet
Upright stroke volume after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
Blood volume after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
Upright plasma catecholamines after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
Quality of life after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet
3 Methods Interventions All participants will be instructed to each 5-6 g of salt per day in their diet In the moderate dietary salt plus additional salt arm participants will receive blinded capsules that contain 6g of salt per day 12x 500g slow- release capsules They will take 2g of salt 3 times per day Participants in the placebo arm will receive blinded capsules that contain 6g of microcrystalline cellulose Protocol compliance will be assessed with 24h urine sodium
Randomization This is a blinded cross-over study The investigators will randomize patients to start with either salt capsules or placebo After the 6-week study arm participants will cross-over to the second study arm
Study Visit Schedule The study will consist of three in-house study sessions a baseline assessment and an assessment at the end of each study arm moderate dietary salt plus additional salt and placebo The baseline visit will serve as a screening visit Each study session will take place over 1 day in the Autonomic Lab at the University of Calgary There will also be four 24hr urine sodium collections and multiple online REDCap surveys
In-Lab Evaluation The in-lab evaluation sessions while consist of autonomic function testing including a 10-minute tilt test blood volume assessment and supine and standing bloodwork An IV will be started for the blood work
Urine Sodium Participants will complete a 24-hr urine sodium test around the time of each in-lab evaluation as well as before the 1 week study wash in
Study Surveys At each assessment point baseline and end of each arm the investigators will send participants a secure REDCap survey link At the end of the study participants will also receive a patient experience survey Participants will receive a total of 4 surveys
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None