Skin Sodium and Salt Sensitivity of Blood Pressure

NCT05976438 | Unknown

• 1 other identifier: A096461
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

Skin Sodium; Salt Sensitivity; Blood Pressure; Heart Disease; Cardiovascular

Outcome Measures

Primary Outcomes (3)

• Concentration of Skin sodium

  This is planned for all participants

  Approximately 8 weeks after receiving each treatment up to week 16 which will be the study completion week

• Concentration of Skin Potassium

  This is planned for all participants

  Approximately 8 weeks after receiving each treatment up to week 16 which will be the study completion week

• Systolic blood pressure

  This is planned for all participants

  All study visits - every 4 weeks up to week 16 which will be the study completion week

Secondary Outcomes (4)

• MRI skin sodium concentration

  Approximately 8 weeks after receiving each treatment up to week 16 which will be the study completion week

• Concentration of Skin glycosaminoglycans

  Approximately 8 weeks after receiving each treatment up to week 16 which will be the study completion week

• Diastolic blood pressure

  All study visits - every 4 weeks up to week 16 which will be the study completion week

• Body weight

  Body weight measurement will be performed at baseline only.

Other Outcomes (1)

• Sodium MRI of kidney

  Approximately 8 weeks after receiving each treatment up to week 16 which will be the study completion week

Study Arms (2)

Open label arm 1

OTHER

Participants will be randomised to AB sequence of drugs A: 1 to 2 weeks of Amlodipine 5mg followed by 6 to 7 weeks of Amlodipine 10mg B: Approximately 8 weeks of 25mg Chlortalidone

Drug: Amlodipine; Drug: Chlortalidone

Open label arm 2

OTHER

Participants will be randomised to BA sequence of drugs B: Approximately 8 weeks of 25mg Chlortalidone A: 1 to 2 weeks of Amlodipine 5mg followed by 6 to 7 weeks of Amlodipine 10mg

Drug: Amlodipine; Drug: Chlortalidone

Interventions

Amlodipine DRUG

Amlodipine 5mg and Amlodipine 10mg will be one of the study drugs the patients will receive.

Open label arm 1; Open label arm 2

Chlortalidone DRUG

Chlortalidone 25mg will be one of the study drugs the patients will receive.

Open label arm 1; Open label arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written informed consent to participate
• Aged 18 or above
• Be hypertensive defined as:
• Currently untreated with an ABPM day time average blood pressure or average home blood pressure of ≥135 mmHg (systolic) or ≥85 mmHg (diastolic)
• Patients who are taking antihypertensive drugs at sub therapeutic doses or in ineffective combinations, and who are felt likely to be controllable on a study drug and willing and able to be washed out, at the discretion of the CI/PI, can enter the study if they meet the above criteria.

You may not qualify if:

• Uncontrolled blood pressure ≥ 180/110mmHg
• Known or suspected secondary hypertension
• Pregnant or breastfeeding women
• Significant sensitivity or contraindications to any of the study medications
• Participants taking lithium or are regularly consuming non-steroidal anti-inflammatory drugs at variable doses
• Requirement to take any of the study drugs continuously e.g. ACEi and heart failure
• Any clinically significant hepatic impairment
• Any clinically significant kidney impairment
• Concurrent participation in another clinical trial or study using systemic vasoactive medications or medications known to interact with the study drugs
• Patients who are deemed unsuitable by the investigator on clinical grounds e.g. an abnormal heart rhythm due to Atrial Fibrillation (AF)

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (2)

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

St Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Hypertension; Heart Diseases

Interventions

Amlodipine; Chlorthalidone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ian Wilkinson

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Sambath

CONTACT

01223 256621; irene.sambath@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 4, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-07

Locations

GB (2)