Issues relate to COVID-19 and staffing challenges, as well as very tight finances.

This blinded cross-over clinical trial will enroll participants with mild stage 1 hypertension to evaluate whether urinary extracellular transcript abundance predicts response to an mineralocorticoid receptor (MR) antagonist, eplerenone.

Eligible participants will have a 2 week wash-in period followed by 4 weeks of treatment with placebo or eplerenone. There will be a 2 week wash out period from study medications and then participants will take the other drug (placebo or eplerenone) for 4 weeks. In addition, participants will also provide urine and blood samples during the trial, have physical assessments, and be monitored for safety.

Inclusion Criteria:

• History of mild stage 1 systemic hypertension as defined by:

  1. Systolic blood pressure (SBP) ≥ 140 millimeters of Mercury (mmHg) or diastolic blood pressure (DBP) ≥ 90 mmHg on 2 occasions and

  2. Treatment with 1-2 antihypertensive medications (stable dose for 6 weeks)

     Exclusion Criteria:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

• Stage 2 hypertension (history of blood pressure ≥ 160/100 mmHg)

• History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension

• Current mineralocorticoid antagonist use

• Type II Diabetes with microalbuminuria

• Primary adrenal insufficiency

• Current glucocorticoid use

• Electrolyte abnormality on baseline laboratory assessment

• Current potassium supplementation

• Positive test for leukocyte esterase on urinalysis

• Creatinine clearance < 50 mL/min on baseline laboratory assessment

• Hyperkalemia

• Potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene)

• Serum potassium >5.0 milliequivalents per liter (mEq/L) on baseline laboratory assessment

• Current use of strong CYP3A4 inhibitors (some include: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir).

• Serum creatinine > 1.5 mg/dL in males on baseline laboratory assessment

• Serum creatinine > 1.3 mg/dL in females

• Current beta blocker use

• Any other condition thought by the Principal Investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study

We will de-identify participant information and will share it with a trusted repository, such as National Institutes of Health (NIH) Figshare or The Inter-university Consortium for Political and Social Research (ICPSR).

We will de-identify and share data obtained from analyzing urinary mRNA biomarkers and measuring the systolic and diastolic blood pressure following consumption of a high-sodium and low-sodium diet. Additionally, specific lab values that support the validity and quality of the study treatment will be shared in a trusted repository.

De-identified data will be deposited into a repository within 1 year of the conclusion of the study.

No additional access restrictions will be placed on the de-identified data, beyond those required by the repository to access or download the data.

• Lab results will be reviewed by an un-blinded co-investigator.
• Dose adjustments will be done by an un-blinded co-investigator who is licensed to prescribe the study drug.
• The study blind will be broken on completion of the clinical study.