Folic Acid Supplementation in Calcific Aortic Valve Disease

• Status: Not yet recruiting
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of folic acid compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Folic Acid

Criteria

Inclusion Criteria:

• Male or female adult ≥ 35 years of age at the time of recruiting.

• Subject has calcific aortic valve disease with mild to moderate aortic valve stenosis as defined by Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on transthoracic echocardiography within 2 weeks prior to randomization and Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization

• Subject provides written informed consent prior to initiation of any study procedures.

• Subject understands and agrees to comply with planned study procedures.

Exclusion Criteria:

• Subject has concomitant moderate or severe mitral or tricuspid valve disease.

• Subject has left ventricular ejection fraction < 50%.

• Subject previous history of aortic valve surgery, pancreatitis, malignant tumor, drug or alcohol abuse.

• Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal range.

• Subjects who cannot undergo Cardiac CT.

• Pregnant or lactating women.

• Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment.