Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial — SPin-D  

End-Stage Renal Disease Clinical Trial

Official title: Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial

Status Completed

Clinical Trial Summary

The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.

Clinical Trial Description

The primary objective of this study is to characterize the safety and tolerability of multiple doses of chronic SPL therapy compared with placebo in maintenance hemodialysis patients and to assess the feasibility of conducting a full-scale, mortality-powered trial of SPL. The effects of SPL compared with placebo on multiple cardiovascular efficacy parameters will also be analyzed. The primary efficacy parameter will be the change in the E' measurement on tissue Doppler echocardiography (TDI) as an index of diastolic function and a surrogate for myocardial fibrosis. Secondary cardiac parameters of interest that will be studied in the overall population or in sub-studies include heart rate variability, circulating markers of fibrosis, and coronary flow reserve (CFR) as an index of microvascular function. These parameters are designed to broaden insight into the potential effects of SPL on cardiac structure and function in individuals with dialysis-dependent ESRD and to assess the feasibility of conducting a full-scale, mortality-powered trial. ;

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT02285920
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Completion date: July 30, 2017