Aortic Valve Stenosis, Calcification of Aortic Valve
Conditions
Keywords
Folic Acid, Calcification of Aortic Valve, Aortic Valve Stenosis
Brief 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.
Detailed description
Folic acid is involved in important physiological activities in the body such as DNA synthesis, cell division and growth and development. Recent studies have shown that folic acid may also have a positive effect on cardiovascular system health. Aortic valve calcification is a cardiovascular disease whose incidence increases progressively with age. Early studies suggest that folic acid may slow the progression of aortic valve calcification by inhibiting cell calcification and promoting calcium deposition. Participants were randomized into two groups: one group was given oral folic acid treatment and the other group was given placebo control. Patients in both groups were observed for aortic valve calcification during the follow-up period, and changes in aortic valve thickness, degree of calcification, and flow were recorded by cardiac ultrasonography, while the incidence of cardiovascular events and adverse effects were assessed.
Interventions
DRUGFolic Acid Oral Tablet
Dietary Supplement: Folic acid 2.5mg/day
DIETARY_SUPPLEMENTPlacebo
Dietary Supplement: Placebo
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic valve calcification | 104 weeks | Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks |
| overall survival | 3 years | overall survival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-major adverse cardiovascular events | 104 weeks | Time-to-major adverse cardiovascular events of cardiac death, non- fatal myocardial infarction, heart failure hospitalization and stroke |
| Aortic valve calcification | at week 52 | Change in aortic valve calcification as measured by Agatston AU using cardiac computed tomography (CT) at week 52 |
| Change in aortic valve stenosis severity | at week 104 | Change in aortic valve stenosis severity as measured by peak transaortic velocity using echocardiography at week 104 as compared to baseline |
Contacts
Primary ContactFei Li, MD
Backup ContactLi Xu, MD
Outcome results
None listed