A Phase 2 interventional study of Folic Acid Oral Tablet and Placebo in Calcification of Aortic Valve and Aortic Valve Stenosis, sponsored by Wuhan Union Hospital, China. Not yet recruiting. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Wuhan Union Hospital, China · Phase 2, Interventional, and Prevention
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.
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.
44 studies on the registry are indexed under Aortic Valve, Calcification of; 15 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 23 interventional studies indexed under Aortic Valve, Calcification of.
Browse Aortic Valve, Calcification of studies →Wuhan Union Hospital, China is the lead sponsor of 229 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Folic acid 2.5 mg/day
Drug: Folic Acid Oral Tablet
Dietary Supplement: Placebo
Dietary Supplement: Placebo
Dietary Supplement: Folic acid 2.5mg/day
Dietary Supplement: Placebo
Aortic valve calcification
Aortic valve calcification as measured by change from baseline in Agatston arbitrary unit (AU) using cardiac computed tomography (CT) at 104 weeks
Time frame: 104 weeks
overall survival
overall survival (OS)
Time frame: 3 years
Time-to-major adverse cardiovascular events
Time-to-major adverse cardiovascular events of cardiac death, non- fatal myocardial infarction, heart failure hospitalization and stroke
Time frame: 104 weeks
Aortic valve calcification
Change in aortic valve calcification as measured by Agatston AU using cardiac computed tomography (CT) at week 52
Time frame: at week 52
Change in aortic valve stenosis severity
Change in aortic valve stenosis severity as measured by peak transaortic velocity using echocardiography at week 104 as compared to baseline
Time frame: at week 104
No study locations are listed for this record.
Plan to share: Yes — we would like to share individual participant data with other researchers 1 years after the trial completely finished
Supporting information: Study protocol, Informed consent form, Clinical study report
Access criteria: All data should only be used for academic research.
Start is estimated for Jul 2023; primary completion for Jul 2025, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Folic Acid
Aortic Valve, Calcification of →