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


  • 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

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