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.