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

Who is this study for? Patients with mild stage 1 hypertension
What treatments are being studied? Eplerenone
Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
Michigan
University of Michigan
Ann Arbor
Time Frame
Start Date: 2023-02
Completion Date: 2023-12-01
Treatments
Placebo_comparator: Placebo
Participants will be randomized to receive 4 weeks of placebo and then 4 weeks of Eplerenone.
Experimental: Eplerenone
Participants will be randomized to receive 4 weeks of Eplerenone and then 4 weeks of Placebo.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov