A Study to Investigate Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis

Launched by KARDIGAN, INC. · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ataciguat to see if it can help slow down the worsening of a heart condition known as moderate calcific aortic valve stenosis (CAVS). This condition involves the narrowing of the aortic valve, which can make it harder for the heart to pump blood. The trial is looking for adults aged 50 and older who have been diagnosed with moderate CAVS and meet certain health criteria, such as having a specific heart function measurement and being able to participate in exercise testing.

If you or someone you know is interested in participating, you will need to ensure you do not have certain heart issues or previous surgeries that could exclude you from the study. Participants will be monitored closely throughout the trial, which is not yet recruiting, meaning they have not started enrolling patients yet. This study is important because it may offer new insights into treating moderate aortic valve stenosis and improving heart health for those affected by this condition.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Adult male or female at least 50 years of age
• 2. Has moderate CAVS as defined by:
• • 1. An AVA of ≥1 cm2 to ≤1.50 cm2
• • 2. An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men
• • 3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Core Laboratory
• • 4. Can perform Cardiopulmonary Exercise Testing (CPET)
• Key Exclusion Criteria:
• • 1. Has had a prior aortic valve replacement, repair, surgery, or intervention
• • 2. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
• • 3. Has known congenital aortic valve disease including bicuspid aortic valve
• • 4. New York Heart Association (NYHA) Class III or Class IV
• • 5. Has heart failure such as cardiomyopathy, congenital heart disease, myocarditis
• • 6. Has coronary artery disease or anticipating coronary stenting surgery
• • 7. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation