Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

Cardiovascular Disease Clinical Trial

Official title:

Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693589
• Other study ID #: KEK-Nr. 115/03
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2008
• Last updated: June 6, 2008
• Start date: January 2005
• Est. completion date: April 2007

Study information

• Verified date: June 2008
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Description:

Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago

• history of percutaneous coronary intervention (PTCA or stenting)

• confirmed consent

Exclusion Criteria:

• myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago

• ongoing treatment with statins

• ongoing vitamin supplementation with folic acid and B vitamins

• <18 years

• active smokers

• uncontrolled arterial hypertension

• renal insufficiency

• atrial fibrillation

• liver disease

• NYHA class >2

• familial hypercholesterolemia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Endothelial Dysfunction
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• folic acid, vitamin B12 and B6 and rosuvastatin
Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated dilatation (FMD)		after 6 weeks of randomized treatment and after 6 weeks of combined treatment	No
Secondary	changes in biochemistry parameters		after 6 weeks of randomized treatment and after 6 weeks of combined treatment	No