Clinical trial

Investigating the Relevance of Skin Sodium and Salt Sensitivity of Blood Pressure in Determining the Response to Anti-Hypertensive Drugs (INTREPID)

Name
A096461
Description
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.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Treatment
Amlodipine
Amlodipine 5mg and Amlodipine 10mg will be one of the study drugs the patients will receive.
Arms:
Open label arm 1, Open label arm 2
Chlortalidone
Chlortalidone 25mg will be one of the study drugs the patients will receive.
Arms:
Open label arm 1, Open label arm 2
Size
60
Primary endpoint
Concentration of Skin sodium
Approximately 8 weeks after receiving each treatment up to week 16 which will be the study completion week
Concentration of Skin Potassium
Approximately 8 weeks after receiving each treatment up to week 16 which will be the study completion week
Systolic blood pressure
All study visits - every 4 weeks up to week 16 which will be the study completion week
Eligibility criteria
Inclusion Criteria: 1. Have given written informed consent to participate 2. Aged 18 or above 3. Be hypertensive defined as: 1. Currently untreated with an ABPM day time average blood pressure or average home blood pressure of ≥135 mmHg (systolic) or ≥85 mmHg (diastolic) OR 2. 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. Exclusion Criteria: 1. Uncontrolled blood pressure ≥ 180/110mmHg 2. Known or suspected secondary hypertension 3. Pregnant or breastfeeding women 4. Significant sensitivity or contraindications to any of the study medications 5. Participants taking lithium or are regularly consuming non-steroidal anti-inflammatory drugs at variable doses 6. Requirement to take any of the study drugs continuously e.g. ACEi and heart failure 7. Any clinically significant hepatic impairment 8. Any clinically significant kidney impairment 9. Concurrent participation in another clinical trial or study using systemic vasoactive medications or medications known to interact with the study drugs 10. Patients who are deemed unsuitable by the investigator on clinical grounds e.g. an abnormal heart rhythm due to Atrial Fibrillation (AF)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-08-04

1 organization

1 product

1 drug

1 indication

Indication
Hypertension