Valvular & structural heart diseaseRandomised controlled trial
Reactivation of Oxidized Soluble Guanylate Cyclase as a Novel Treatment Strategy to Slow Progression of Calcific Aortic Valve Stenosis: Preclinical and Randomized Clinical Trials to Assess Safety and Efficacy
- Mechanistic study with randomised controlled trials (phase I and phase II)
- placebo-controlled
- preclinical (human tissue, cells, mice)
Authors' conclusion
Collectively, this study highlights the therapeutic potential of the targeted restoration of the diseased/inactive form of sGC for treatment of FCAVS.
Study context
- Population
- Patients with moderate aortic valve stenosis; excised human aortic valve tissue, aortic valve interstitial cells, mouse aortic valves
- Comparison
- Ataciguat vs placebo
Primary result
As reported in the abstract
Progression of aortic valve calcification (phase II) · 6 months
- Ataciguat slowed progression of aortic valve calcification vs placebo
- Ataciguat tended to slow progression of valvular and ventricular dysfunction
Safety
Safety/tolerance (phase I) · 2 weeks
- Ataciguat safe and well tolerated in patients with moderate fibrocalcific aortic valve stenosis (FCAVS)
Original publication
Reactivation of Oxidized Soluble Guanylate Cyclase as a Novel Treatment Strategy to Slow Progression of Calcific Aortic Valve Stenosis: Preclinical and Randomized Clinical Trials to Assess Safety and Efficacy. Circulation. Published 24 February 2025. doi:10.1161/circulationaha.123.066523
Summarised from the published abstract; every number is checked against it