Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT04258332
Eligibility Criteria:
Inclusion Criteria:
Potentially eligible individuals must consent to and be willing to adhere to the study protocol. We will include individuals not taking anti-HTN medications, i.e. normotensives and untreated hypertensives, and individuals with controlled HTN by use of ≤ 3 anti-HTN medications.
Exclusion Criteria:
* Unwilling to adhere to the study protocol
* Resistant HTN, defined as taking ≥ 4 anti-HTN medications to control BP or uncontrolled BP despite ≥ 3 anti-HTN medications that includes a diuretic
* Contraindications to high- or low-salt diet (e.g. heart, renal, or liver failure, postural orthostatic tachycardia syndrome)
* Use of salt tabs, fludricortisone, midodrine
* Contraindications to 24hr ABPM: bilateral upper extremity lymphedema, cuff will not fit
* Medical contraindications to foods, e.g. celiac disease, nut allergy, egg allergy, etc.
* Year 35 core exam systolic BP \< 90 or \> 160 mm Hg or diastolic BP \< 50 or \> 100 mm Hg
* Current use of steroids, NSAIDS, anti-inflammatories
* Rheumatologic condition (e.g. Lupus, Rheumatoid Arthritis, Psoriatic arthritis, Inflammatory Bowel Disease, Multiple Sclerosis
* Immune deficiency or immunosuppressed
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT04258332
Study Brief:
Protocol Section:
NCT04258332