Clinical Trials Logo
  1. Home
  2. Cardiovascular Disease
  3. NCT00169910

VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients

Cardiovascular Disease Clinical Trial

Official title:
VIP: Vascular Imaging Project. Prospective Randomized Study on the Effect of AUC-monitored Treatment With Steroids Combined With Either a Calcineurin Inhibitor or Mycophenolate Mofetil on the Progression of Subclinical Cardiovascular Disease in Renal Transplant Recipients.

Clinical Trial Summary

This is a prospective randomized study to compare the influence of area under the curve (AUC)-monitored dual treatment with steroids in combination with either a calcineurin inhibitor (CNI) or mycophenolate mofetil (MMF) on the progression of subclinical cardiovascular disease in renal transplant recipients.

Since CNI have a detrimental effect on cardiovascular risk factors, it is the researchers' hypothesis that renal recipients after CNI withdrawal will have more reduction of markers of cardiovascular disease.

Clinical Trial Description

Stable renal transplant patients on maintenance immunosuppressive therapy with steroids, a calcineurin inhibitor (CNI) and mycophenolate mofetil (MMF) will be randomized for AUC-monitored withdrawal of either CNI or MMF.

The progression of cardiovascular markers will be assessed by yearly measurements of Intima Media Thickness, Pulse Wave Velocity and Left Ventricular Hypertrophy in both groups.

The duration of the study will be 3 years and the target sample size is 100 patients per arm ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00169910
Study type Interventional
Source Leiden University Medical Center
Contact
Status Completed
Phase Phase 4
Start date December 2005
Completion date December 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Completed NCT02502812 - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects Phase 1
Recruiting NCT04216342 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers Phase 1
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT03646656 - Heart Health Buddies: Peer Support to Decrease CVD Risk N/A
Completed NCT02081066 - Identification of CETP as a Marker of Atherosclerosis N/A
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Recruiting NCT03095261 - Incentives in Cardiac Rehabilitation N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Completed NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Completed NCT02711878 - Healing Hearts and Mending Minds in Older Adults Living With HIV N/A
Completed NCT02868710 - Individual Variability to Aerobic Exercise Training N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Recruiting NCT02885792 - Coronary Artery Disease in Patients Suffering From Schizophrenia N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Completed NCT02657382 - Mental Stress Ischemia: Biofeedback Study N/A
Completed NCT02272946 - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk Phase 2
Completed NCT02640859 - Investigation of Metabolic Risk in Korean Adults
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment