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

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

Outcome

Mixed primary results

registry analysis (superiority test); Hydralazine/Isorsorbide Dinitrate vs Placebo; p = 0.04; poisson NCT02228408 ↗

registry COUNT_OF_PARTICIPANTS Hydralazine/Isorsorbide Dinitrate: intradialytic hpypotension: 1 Participants NCT02228408 ↗

registry COUNT_OF_PARTICIPANTS Placebo: intradialytic hpypotension: 6 Participants NCT02228408 ↗

registry analysis (superiority test); Hydralazine/Isorsorbide Dinitrate vs Placebo; p = 0.19; t-test, 2 sided NCT02228408 ↗

registry analysis (superiority test); Hydralazine/Isorsorbide Dinitrate vs Placebo; p = 0.34; t-test, 2 sided NCT02228408 ↗

Publications

• Mugendi GA, Mutua FM, Natale P, Esterhuizen TM, Strippoli GF. Calcium channel blockers for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 Oct 1;10(10):CD011064. doi: 10.1002/14651858.CD011064.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydralazine	Small molecule	75 mg	—
Subject	Isorsorbide Dinitrate	Unknown	40 mg	—

Indications