Table 1.
Current Trials Investigating the Effects of Novel Therapies on Progression of AS
| Trial Name | NCT # | Therapy | Population | Imaging Endpoints | Primary Outcome |
|---|---|---|---|---|---|
| EAVall (Early Aortic Valve Lipoprotein(a) Lowering) | NCT02109614 | Niacin vs. placebo | 238 participants with aortic sclerosis or mild AS | CT calcium score Echo |
Change in CT calcium score at 2 yrs |
| SALTIRE-II (Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis) | NCT02132026 | Alendronate or denosumab vs. placebo | 150 patients with AV Vmax >2.5 m/s and grade 2–4 calcification on echo | CT calcium score Echo 18F-NaF PET-CT |
Change in CT calcium score at 2 yrs |
| PCSK9 Inhibitors in the Progression of Aortic Stenosis | NCT03051360 | PCSK9 inhibitor vs. placebo | 140 patients with mild to moderate AS | CT calcium score Echo 18F-NaF PET-CT |
Change in calcium score and 18F-NaF PET activity at 2 yrs |
| BASIK2 (Bicuspid Aortic Valve Stenosis and the Effect of Vitamin K2 on Calcium Metabolism on 18F-NaF PET/MRI) | NCT02917525 | Vitamin K2 vs. placebo | 44 patients with a bicuspid AV and mild to moderate calcification on echo | CT calcium score Echo 18F-NaF PET-MRI |
Change in 18F-NaF PET activity at 6 months |
| CALCIFICA (Value of Oral Phytate [InsP6] in the Prevention of Progression of Cardiovascular Calcifications) | NCT01000233 | Phytate vs. placebo | 250 patients with grade 2 or 3 AV calcification on echo | CT calcium score | CT calcium score at 2 yrs |
| ASPEN (Aortic Stenosis and Phosphodiesterase Type 5 Inhibition) | NCT01275339 | Tadalafil vs. placebo | With moderate to severe AS (AVA <1.5 cm) | MRI Echo |
Change in LV mass at 6 months Change in diastolic function on echo Change in LV longitudinal strain on echo |
| CAVS (A Study Evaluating the Effects of Ataciguat [HMR1766] on Aortic Valve Calcification) | NCT02481258 | Ataciguat (HMR1766) vs. placebo | 35 patients with AVA between 1 and 2 cm2 and calcium score >300 AU + EF >50%. | CT calcium score Echo |
Change in CT calcium score at 6 and 12 months |
A summary of current trials employing imaging endpoints to assess the effects of novel therapies by utilizing imaging endpoints.
AS = aortic stenosis; AU = arbitrary unit(s); AV = aortic valve; AVA = aortic valve area; CT = computed tomography; echo = echocardiography; EF = ejection fraction; 18F-NaF = radiolabeled sodium fluoride; LV = left ventricular; MRI = magnetic resonance imaging; NCT = national clinical trial; PCSK9 = proprotein convertase subtilisin/kexin type 9; PET = positron emission tomography; Vmax = maximum volume.