Status:
COMPLETED
Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Chronic Hemodialysis (ESRD)
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 ch...
Detailed Description
Sixteen patients receiving maintenance hemodialysis will be randomized to 26 weeks of therapy with combination hydralazine/isosorbide dinitrate or placebo. Study medications will be titrated to goal d...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02228408
Start Date
August 28 2017
End Date
May 7 2019
Last Update
April 27 2021
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115