Established cardiovascular disease with elevated levels of homocystein
Conditions
Interventions
Trade Name: Huma-Folacid
Product Name: Huma-Folacid
Product Code: B03BB01
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name
Sponsors
Semmelweis University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1./ age between 18-75 years. 2./ coronary heart disease (myocardial infarct in anamnesis, positive coronarography), or defined peripheral obliterative arterial disease by Doppler sonography, or carotid artery disease by color duplex ultrasonography. 3./ hyperhomocysteinemia. 4./ signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1./ known hypersensitivity to folic acid or ascorbic acid 2./ disabled 3./ gravidity or lactation 4./ elevated liver function (3x) 5./ atrial fibrillation, extrasystolia 6./ undefined megaloblastic anemia 7./ known malignancy 8./ known nephrolithiasis 9./ situation that results the change in stabil medical treatment 10./ nitrate treatment 11./ diabetes mellitus 12./ cholesterin level higher than 6.5 mmol/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure endothel dependent and endothel independent vasodilation in patients with established cardiovascular disease and hyperhomocysteinemia with laser Doppler flowmetry before and after folic acid and ascorbic acid treatment ;Secondary Objective: To measure pulse wave velocity in patients with established cardiovascular disease and hyperhomocysteinemia before and after folic acid and ascorbic acid treatment. To measure hemodynamic changes in patients with established cardiovascular disease and hyperhomocysteinemia with beat to beat blood pressure monitoring before and after folic acid and ascorbic acid treatment. To measure homocystein level in patients with established cardiovascular disease and hyperhomocysteinemia before and after folic acid and ascorbic acid treatment. ;Primary end point(s): Flow change by laser Doppler flowmetry | — |
Countries
Hungary
Outcome results
None listed