Hypertension
Conditions
Keywords
Hypertension, Platelet activation, Platelet aggregation, Chlorthalidone
Brief summary
This will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is that CTD has different effects on platelet activation and aggregation than HCTZ.
Interventions
Sponsors
Dialysis Clinic, Inc.
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men or women age 19 or older * Not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements * No use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, NSAID medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period * Systolic blood pressure \> 110 mmHg and diastolic blood pressure \> 60 mmHg * Non-smoker
Exclusion criteria
* Previous adverse reaction or allergy to HCTZ, CTD, or ASA * Severe sulfonamide hypersensitivity (anaphylaxis or Stevens-Johnson syndrome) * Diagnosis of any chronic disease or condition * History of gout or hyperuricemia * History of pancreatitis * History of systemic lupus erythematosus (SLE) * History of hypokalemia requiring treatment * Pregnant or planning to become pregnant during the study period * Breastfeeding * History of hypotension * History of gastrointestinal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean fluorescence intensity of PAC-1 | 2 weeks | The primary endpoint for this study will be the change in mean fluorescence intensity (MFI) of the platelet activation marker PAC-1 due to HCTZ, CTD, and aspirin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD62P expression | 2 weeks | Change in platelet expression of CD62P (p-selectin) in response to CTD, HCTZ, and ASA. |
| Change in platelet aggregation | 2 weeks | Change in platelet aggregation measured by flow cytometry in response to CTD, HCTZ, and ASA |
Countries
United States
Contacts
Primary ContactSandy Byers, RN
Backup ContactCaroline Nubel, BS
Outcome results
None listed