A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522176-86-01

Enrollment

293

Registered

2026-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Calcific Aortic Valve Stenosis (CAVS)

Brief summary

1. (Part B) Percent change in AVA as measured by echocardiogram from baseline to Week 48, 2. (Part B) Change in peak VO2 as assessed by CPET from baseline to Week 48

Detailed description

1. (Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48., 2. (Part B) Time to decision to proceed with TAVR/SAVR or all-cause death; Percentage of participants with AS progression to AVA <1.0cm2 at Week 48

Interventions

DRUGAtaciguat

DRUGPlacebo to match IMP/ataciguat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. (Part B) Percent change in AVA as measured by echocardiogram from baseline to Week 48, 2. (Part B) Change in peak VO2 as assessed by CPET from baseline to Week 48	—

Secondary

Measure	Time frame
1. (Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48., 2. (Part B) Time to decision to proceed with TAVR/SAVR or all-cause death; Percentage of participants with AS progression to AVA <1.0cm2 at Week 48	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 11, 2026