Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Eplerenone

Criteria

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