Status:
WITHDRAWN
Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- History of mild stage 1 systemic hypertension as defined by:
- Systolic blood pressure (SBP) ≥ 140 millimeters of Mercury (mmHg) or diastolic blood pressure (DBP) ≥ 90 mmHg on 2 occasions and
- Treatment with 1-2 antihypertensive medications (stable dose for 6 weeks)
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04746495
Start Date
February 1 2023
End Date
December 1 2023
Last Update
February 21 2023
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109