drugset / Trial / NCT02228408

Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD

NCT02228408

Phase 4 Completed 17 enrolled Brigham and Women's Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is a pilot study designed to compare the safety and cardiovascular effects of 26 weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in patients receiving chronic hemodialysis. The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it will improve heart function as well blood flow/blood vessel supply.

Timeline

Start
2017-08-28
Primary completion
2019-05-07
Completion
2019-05-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydralazine Small molecule 75 mg
Subject Isorsorbide Dinitrate Unknown 40 mg