Ataciguat for Aortic Valve Stenosis

(KATALYST-AV Trial)

Recruiting at 48 trial locations

Overseen By Kardigan Clinical Trial Information Team

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kardigan, Inc.

Disqualifiers: Heart failure, Coronary artery disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1410 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

Are You a Good Fit for This Trial?

This trial is for adults with moderate calcific aortic valve stenosis, which is a heart valve disease. Participants should not have other conditions that could interfere with the study or pose additional risks.

Inclusion Criteria

Can perform Cardiopulmonary Exercise Testing (CPET)

Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Core Laboratory

I am 50 years old or older.

Exclusion Criteria

I have had surgery or a procedure on my aortic valve before.

I have an irregular heartbeat or long-term atrial fibrillation.

I have a heart condition like cardiomyopathy or congenital heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive ataciguat or placebo to investigate the effect on aortic valve calcium deposition and peak oxygen consumption

48 weeks

Treatment Part B

Evaluation of ataciguat's effect on peak VO2 and aortic valve area reduction

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ataciguat

Trial Overview The study aims to determine if ataciguat can slow down the worsening of moderate calcific aortic valve stenosis compared to a placebo. It's essentially testing whether this drug can help manage heart valve disease better than no treatment.

How Is the Trial Designed?

Group I: Ataciguat Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Kardigan, Inc.

Lead Sponsor

Trials

1

Recruited

700+