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

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Hemodialysis (ESRD)

In brief

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.

Key facts

Study ID

NCT02228408

Run by

Brigham and Women's Hospital

People needed

17

Starts

2017-08-28

Expected to finish

2019-05-07

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Maintenance hemodialysis therapy for end-stage renal disease
• Age 18-85 years
• ≥ 90 days since dialysis initiation
• Ability to provide informed consent
• Pre-dialysis seated systolic blood pressure measurements must be ≥ 120 mm Hg in the 2 weeks before enrollment and on the day of randomization.

You may not qualify if…

• Serum potassium ≥6.5 mEq/L within 2 months prior to screening
• Unscheduled dialysis for hyperkalemia within the 3 months prior to screening
• Hypotension defined as pre-dialysis SBP <100 mm Hg (seated measurement) within 4 weeks prior to enrollment
• Recurrent intra-dialytic hypotension, defined as systolic blood pressure <80 mm Hg during ≥3 dialysis sessions per 30-day rolling period or treatment for either hypotension or symptoms of hypotension if systolic blood pressure is < 100 mm Hg during ≥3 dialysis sessions per 30-day rolling period.
• Mitral valve repair or replacement
• Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging
• Prior coronary artery bypass graft
• Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 6 months
• Expected survival < 6 months
• Allergy to study medications (ISD, HY, adenosine/diprimidole)
• Active use of sildenafil, vardenafil or tadalafil
• History of severe aortic stenosis or other cause of LV outflow obstruction
• Pregnancy, anticipated pregnancy, or breastfeeding, confirmed by serum pregnancy test on the day of PET scan
• Incarceration
• Participation in another intervention study
• Use of monoamine oxidase inhibitors
• Contraindication to adenosine including
• 2nd or 3rd degree heart block, sick sinus syndrome or symptomatic bradycardia (without a functioning pacemaker)
• moderate or severe asthma
• chronic obstructive pulmonary disease
• Active use of any of the study medications unless participant and physician willing to discontinue prior to enrollment.

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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