Genetic testing for predicting early aortic valve disease in patients with bicuspid aortic valves

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how genetic mutations and clonal hematopoiesis affect the progression of early calcification in aortic valves among patients with bicuspid aortic valves. Over a recruitment period of one year, the study will enroll 240 participants, including those with both early aortic valve calcification and normal valve function. Participants will be followed for two years to assess the impact of these genetic factors on valve disease progression. The study will utilize cardiac imaging techniques to confirm the presence of bicuspid aortic valves and measure the severity of aortic stenosis or regurgitation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with confirmed bicuspid aortic valves based on cardiac imaging (echocardiography, CT, MRI) or surgical findings.
2. Early aortic valve calcification group: Patients aged 20-80 with moderate or greater aortic valve stenosis/regurgitation.
3. Normal functioning aortic valve group: Patients aged 20-80 with mild or less aortic valve stenosis/regurgitation.
4. Patients who understand the purpose of the study and voluntarily consent to participate.

Exclusion Criteria:

1. Patients with malignant neoplastic diseases or other conditions, such as cerebrovascular accidents, which predict survival of less than 6 months.
2. Patients with unclear presence of bicuspid aortic valves.
3. Patients with stage 3 or higher chronic kidney disease.
4. Patients with other inherited cardiac conditions.
5. Patients with cognitive impairment or hemodynamically unstable patients who have difficulty understanding the study content.

Where it's running

• Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Iksung Cho — Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
• Study coordinator: Iksung Cho
• Email: iksungcho@yuhs.ac
• Phone: 82-2-2228-8442

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Transcatheter and Surgical Aortic Valve Replacement for Bicuspid Aortic Valve Patients

  This study is testing whether a new heart valve replacement method works better than the traditional surgery for people with severe aortic stenosis and a bicuspid aortic valve.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT06817148

• Assessing changes in aortic diameter after valve replacement

  This study looks at how the size of the aorta changes after patients have a heart valve replacement to see if it gets bigger or stays the same, especially for those who already had a larger aorta.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT05739253

• Evaluating outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valves

  This study is testing how well transcatheter aortic valve replacement works for people with severe aortic stenosis caused by a bicuspid aortic valve.

  Recruiting Cedars-Sinai Medical Center · Los Angeles, California · NCT03836521

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.