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End Stage Renal Disease | L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD

End Stage Renal Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

End Stage Renal Disease

Hemodialysis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Spironolactone

Dietary Supplement:L-arginine

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Spironolactone + PlaceboSpironolactone 25 mg by mouth daily + Placebo L-arginine-liquid formulation by mouth 3 times daily

Double PlaceboPlacebo spironolactone-1 tablet by mouth daily + Placebo L-arginine liquid formulation by mouth 3 times daily

Spironolactone + L-arginineSpironolactone 25 mg daily + L-arginine 3 grams orally 3 times daily

L-arginine + PlaceboL-arginine 3 grams by mouth 3 times daily + Placebo spironolactone 1 tablet by mouth daily

Study Status

Withdrawn

Start Date: September 2013

Completed Date: July 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in coronary Flow Reserve (PET)

Secondary Outcome: Association between coronary flow reserve (CFR) and tissue doppler index (E')

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Brigham and Women's Hospital

Collaborator: Massachusetts General Hospital

More information:https://clinicaltrials.gov/show/NCT01855334

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