Testing a New Treatment to Lower Heart Risks in People With High Blood Pressure
- Trial ID:
- IRB-26-8720
- Athena Philis-Tsimikas, M.D.
Inclusion Criteria
Patients must:
- Be 18 years or older for patients with established cardiovascular disease (CVD)
Be 55 years or older for patients with high risk for CVD
Have established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
Have treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
Exclusion Criteria
Patients must not:
- Have a known history of secondary hypertension
Have symptomatic orthostatic hypotension
Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×upper limit of normal (ULN)
Have a total serum bilirubin >1.5×ULN
Have an international normalized ratio (INR) >1.5
Have a serum potassium >4.8 mEq/L
Have an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2
Additional Info
Participants will be randomized, like the flip of a coin, to receive either the investigational study medication 300mg zilebesiran or placebo (no active ingredients). The treatment period will last approximately 2.5 - 5 years.