Advertisement

Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3

Sponsored by Vanderbilt University

Phase Quota
Phase 3

The purpose of the study is to see how two classes of blood pressure medications,angiotensin-converting enzyme inhibitors (Ace inhibitors) and angiotensin receptor blockers (ARBs), differ in their long term effects on certain chemicals in the body and on the carotid arteries.

Study Start Date: January 2010

Estimated Completion Date: June 2015

Specialties: Family Medicine: Basic Science/Genetics Internal Medicine: Basic Science/Genetics,Nephrology/Urology Nephrology: Dialysis

Interventions

  • Drug: valsartan (ARB)
  • Drug: Placebo
  • Drug: ramipril (ACE inhibitor)

Inclusion criteria

  • Age 18 years or older
  • On thrice weekly chronic hemodialysis for at least 6 months
  • Clinically stable, adequately dialyzed (single-pool Kt/V > 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

Exclusion criteria

  • Body mass index > 35 mg/kg2
  • History of functional transplant less than 6 months prior to study
  • Use of anti-inflammatory medications other than aspirin < 325 mg/d
  • Use of immunosuppressive drugs within 1 month prior to study
  • History of active connective tissue disease
  • History of acute infectious disease within one month prior to study
  • AIDS (HIV seropositivity is not an exclusion criteria)
  • History of myocardial infarction or cerebrovascular event within 3 months
  • Advanced liver disease
  • Gastrointestinal dysfunction requiring parental nutrition
  • Active malignancy excluding basal cell carcinoma of the skin
  • History of ACE inhibitor-associated cough or angioedema
  • Ejection fraction less than 40%
  • Inability to discontinue ACE inhibitor or ARB
  • Predialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
  • Anticipated live donor kidney transplant
  • Use of vitamin E > 60 IU/d or vitamin C > 500 mg/d
  • Pregnancy, breast-feeding or child-bearing potential
  • History of poor adherence to hemodialysis or medical regimen
  • Inability to provide consent

Study Locations And Contact Information

  • Vanderbilt University Medical Center, Nashville Tennessee
  • Vanderbilt University Medical Center, Nashville Tennessee

Feature this Clinical Trial

Get your trial in front of 1000s of physicians and patients.
Visit ClinicalTrialsLocator.com to find out how you can feature this clinical trial.

Advertisement