Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976438
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-07-17
Brief Title:
Skin Sodium and Salt Sensitivity of Blood Pressure
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
Investigating the Relevance of Skin Sodium and Salt Sensitivity of Blood Pressure in Determining the Response to Anti-Hypertensive Drugs INTREPID
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
INTREPID
Brief Summary:
Eating too much salt raises blood pressure and the risk of having a heart attack or stroke The investigators do not fully understand why salt raises blood pressure but storage of sodium in the body particularly in the skin may be important For this reason the investigators wish to study the link between skin sodium blood pressure and cardiovascular risk in patients with high blood pressure of different ethnicities using techniques such as skin biopsy and magnetic resonance imaging MRI The results will provide detailed information on skin sodium storage and help us better understand the effects of blood pressure medications on these mechanisms Ultimately the investigators aim to develop personalized treatment guidelines for clinical use
Detailed Description:
The physiological basis of salt sensitivity of blood pressure SSBP is poorly understood and determining which patients have SSBP is not straightforward Furthermore determining salt sensitivity requires direct intervention tracking changes in blood pressure after salt challenge or depletion over several days This makes identifying salt-sensitive individuals impractical in a clinical setting hindering its application It is crucial that the investigators elucidate the underlying mechanisms of salt-sensitivity and through this understanding develop a biomarker of SSBP for clinical use
From a review of recent studies it appears that in the short-term accumulation of skin sodium during high salt intake attenuates the blood pressure response while in the long-term high skin sodium levels indicate a tendency for SSBP hypertension and elevated cardiovascular risk The reasons for this are not clear and merit further investigation By refining methods for quantification of skin sodium and expanding its use in hypertension research the clinicians can improve patient assessment treatment prescription and disease monitoring
Using skin biopsy and sodium MRI provides a unique opportunity to study skin sodium handling and SSBP during antihypertensive treatment and can provide insights into why hypertensives and certain ethnic groups have a higher incidence of SSBP Sodium MRI may also help increase our understanding of the mechanisms by which diuretics work both systemically and in the kidney and provide a way to identify salt-sensitive individuals for targeted clinical intervention
Hypotheses
1 Skin sodium decreases with salt-dependent diuretic treatments but not salt-independent calcium channel blocker treatments
2 Diuretic-induced reductions in skin sodium correlate with reductions in blood pressure
3 Skin sodium is higher in populations traditionally known to be more salt sensitive such hypertensive patients of black ethnicity
Patients will be enrolled on to a randomised open-label two-treatment two-period crossover treatment The hypertensive medication used in this study are Amlodipine 5 or 10mg and Chlortalidone 25mg
The duration for individual participants will be approximately 16 weeks Participants will have a total of 7 visits including screeningenrolment visit 1 and baseline visit visit 2
From a review of recent studies it appears that in the short-term accumulation of skin sodium during high salt intake attenuates the blood pressure response while in the long-term high skin sodium levels indicate a tendency for SSBP hypertension and elevated cardiovascular risk The reasons for this are not clear and merit further investigation By refining methods for quantification of skin sodium and expanding its use in hypertension research the clinicians can improve patient assessment treatment prescription and disease monitoring
Using skin biopsy and sodium MRI provides a unique opportunity to study skin sodium handling and SSBP during antihypertensive treatment and can provide insights into why hypertensives and certain ethnic groups have a higher incidence of SSBP Sodium MRI may also help increase our understanding of the mechanisms by which diuretics work both systemically and in the kidney and provide a way to identify salt-sensitive individuals for targeted clinical intervention
Hypotheses
1 Skin sodium decreases with salt-dependent diuretic treatments but not salt-independent calcium channel blocker treatments
2 Diuretic-induced reductions in skin sodium correlate with reductions in blood pressure
3 Skin sodium is higher in populations traditionally known to be more salt sensitive such hypertensive patients of black ethnicity
Patients will be enrolled on to a randomised open-label two-treatment two-period crossover treatment The hypertensive medication used in this study are Amlodipine 5 or 10mg and Chlortalidone 25mg
The duration for individual participants will be approximately 16 weeks Participants will have a total of 7 visits including screeningenrolment visit 1 and baseline visit visit 2
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