Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Washington
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Ramipril; Valsartan

Criteria

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 or Urea Reduction Ratio (URR) > 65%] thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

Exclusion Criteria:

• History of functional transplant less than 6 months prior to study

• 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 (intolerable) or angioedema

• Ejection fraction less than 30%

• Inability to discontinue ACE inhibitor or ARB

• Predialysis potassium repeatedly higher than 6.0 mmol/L (confirmed on a repeated blood draw)

• Anticipated live donor kidney transplant

• Pregnancy or breast-feeding

• History of poor adherence to hemodialysis or medical regimen

• Inability to provide consent