L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD (LAST-D)
End Stage Renal Disease, Hemodialysis
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Dialysis, ESRD, Cardiovascular disease, spironolactone, L-arginine, myocardial perfusion, coronary flow reserve, diastolic function
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
- Brigham & Women's Hospital
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Experimental
Spironolactone + Placebo
Double Placebo
Spironolactone + L-arginine
L-arginine + Placebo
Spironolactone 25 mg by mouth daily + Placebo L-arginine-liquid formulation by mouth 3 times daily
Placebo spironolactone-1 tablet by mouth daily + Placebo L-arginine liquid formulation by mouth 3 times daily
Spironolactone 25 mg daily + L-arginine 3 grams orally 3 times daily
L-arginine 3 grams by mouth 3 times daily + Placebo spironolactone 1 tablet by mouth daily