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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

Primary Purpose

Cardiovascular Disease, Endothelial Dysfunction

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
folic acid, vitamin B12 and B6 and rosuvastatin
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    R

    V

    Arm Description

    Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks

    Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin

    Outcomes

    Primary Outcome Measures

    Flow mediated dilatation (FMD)

    Secondary Outcome Measures

    changes in biochemistry parameters

    Full Information

    First Posted
    June 5, 2008
    Last Updated
    June 6, 2008
    Sponsor
    Insel Gruppe AG, University Hospital Bern
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00693589
    Brief 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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Insel Gruppe AG, University Hospital Bern

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Disease, Endothelial Dysfunction
    Keywords
    endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    R
    Arm Type
    Active Comparator
    Arm Description
    Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
    Arm Title
    V
    Arm Type
    Active Comparator
    Arm Description
    Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    folic acid, vitamin B12 and B6 and rosuvastatin
    Other Intervention Name(s)
    Crestor
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Flow mediated dilatation (FMD)
    Time Frame
    after 6 weeks of randomized treatment and after 6 weeks of combined treatment
    Secondary Outcome Measure Information:
    Title
    changes in biochemistry parameters
    Time Frame
    after 6 weeks of randomized treatment and after 6 weeks of combined treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kerstin Wustmann, MD
    Organizational Affiliation
    Cardiology, Inselspital, University hospital Bern
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Yves Allemann, MD
    Organizational Affiliation
    Cardiology, Inselspital, University hospital Bern
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    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

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