KATALYST-AV is a phase 3 clinical study for adults 50 and older living with moderate calcific aortic valve stenosis (CAVS).
KATALYST-AV aims to investigate the effectiveness of the investigational medication, ataciguat, compared to placebo to slow the buildup of calcium in the aortic valve in adults with moderate CAVS. It will also assess the safety of the investigational medication, its tolerability, and how it is processed in the body.
Study participants may be able to join the study if they meet the following requirements:
Must be 50 years of
age or older
Confirmed diagnosis of moderate calcific aortic valve stenosis (CAVS)
Must not have had prior aortic valve replacement, repair, or intervention
Must be able to understand and comply with all study procedures
Other study eligibility requirements will apply.
See if You May Qualify
Over time, calcium deposits can build up on the aortic valve, causing it to become stiff and narrow, which makes it harder for blood to flow from the heart to the rest of the body. This results in a condition known as calcific aortic valve stenosis (CAVS). CAVS develops gradually with age and does not typically cause symptoms initially. A healthcare provider may first detect it by listening to your heart with a stethoscope, hearing a murmur caused by the narrow valve. The diagnosis is then confirmed with tests like echocardiograms or other heart imaging studies. Since it primarily affects older adults, regular heart check-ups are essential for early detection and management. Currently, no medications have been shown to slow its progression. If the degree of aortic valve narrowing becomes severe, an aortic valve replacement by surgery is the only treatment option.
• Chest pain or chest tightness
• Shortness of breath, especially during exertion
• Fatigue, particularly with increased activity
• Rapid or fluttering heartbeat
To learn more, talk to your doctor or visit:
Participation in the KATALYST-AV study lasts up to 3 years. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have prior to deciding whether to join the study, and you may leave the study at any time, for any reason.
The study medication in KATALYST-AV refers to ataciguat or placebo. Ataciguat is an investigational medication. The KATALYST-AV study aims to test whether ataciguat is tolerable and slows the progression of calcific aortic valve stenosis.
If you qualify for the KATALYST-AV study, you have a 50% chance of receiving ataciguat and a 50% chance of receiving a placebo, a substance with no active ingredients that is used to help measure the true effectiveness of the treatment.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) and it can only be used in clinical research studies like the KATALYST-AV study with oversight by regulatory authorities like the FDA or the EMA. Note that ataciguat has not been previously approved for any use.
Here are some common questions and answers about study participation.
Clinical studies help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical study, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures.
Study participation usually involves visiting a clinic in-person regularly, taking an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in a clinical research study is your choice, and you may stop at any time.