L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD

• Status: Withdrawn
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Cardiovascular disease is the primary cause of death in patients with end stage renal disease (ESRD). New research suggests that the high risk of death may be partly due to high levels of fibrosis and a loss of small blood vessels in the heart of patients with dialysis-dependent ESRD. This study is designed to compare the effects of two different drugs, spironolactone and L-arginine, with placebo on structure and function of the heart in individuals with dialysis-dependent ESRD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Joslin Diabetes Center; Massachusetts General Hospital
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• Chronic dialysis therapy for End Stage Renal Disease

• Age 21-85

Exclusion Criteria:

• Hyperkalemia requiring unscheduled dialysis within 3 months

• Pre-dialysis potassium ≥6.5 meq/L within 3 months

• Hypotension defined as SBP <100

• Recurrent intra-dialytic hypotension defined as recurrent cramping, light-headedness, or hypotension requiring infusion of saline or other intervention or otherwise limiting ability to achieve dry weight. Or SBP <80

• History of myocardial infarction

• History of coronary artery bypass surgery

• Non revascularized coronary disease >90%

• Mitral valve repair or replacement

• Severe mitral valve disease

• Renal transplant expected within 9 months

• Expected survival < 9 months

• Pregnant

• Prisoners

• Unable to provide consent

• Allergy to spironolactone or L-arginine

• Digitalis use

• 1st or 2nd degree heart block