Chronic Hemodialysis (ESRD) Clinical Trial
— HIDEOfficial title:
A Phase IV Randomized, Double-blind, Active-controlled, Single-center Study of the Safety and Effects on Cardiac Structure and Function of Hydralazine and Isosorbide Dinitrate in Patients With Hemodialysis Dependent ESRD
| Verified date | March 2021 |
| Source | Brigham and Women's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | May 7, 2019 |
| Est. primary completion date | May 7, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria 1. Maintenance hemodialysis therapy for end-stage renal disease 2. Age 18-85 years 3. = 90 days since dialysis initiation 4. Ability to provide informed consent 5. 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 1. Serum potassium =6.5 mEq/L within 2 months prior to screening 2. Unscheduled dialysis for hyperkalemia within the 3 months prior to screening 3. Hypotension defined as pre-dialysis SBP <100 mm Hg (seated measurement) within 4 weeks prior to enrollment 4. 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. 5. Mitral valve repair or replacement 6. Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging 7. Prior coronary artery bypass graft 8. Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 6 months 9. Expected survival < 6 months 10. Allergy to study medications (ISD, HY, adenosine/diprimidole) 11. Active use of sildenafil, vardenafil or tadalafil 12. History of severe aortic stenosis or other cause of LV outflow obstruction 13. Pregnancy, anticipated pregnancy, or breastfeeding, confirmed by serum pregnancy test on the day of PET scan 14. Incarceration 15. Participation in another intervention study 16. Use of monoamine oxidase inhibitors 17. 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 18. Active use of any of the study medications unless participant and physician willing to discontinue prior to enrollment. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Brigham & Women's Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Brigham and Women's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of Hypotension, Serious Adverse Events, GI Events and Cardiovascular Death | Rate of primary Safety Outcomes(hypotension, serious adverse events, GI events and CV death) | 6 months | |
| Primary | Efficacy-Change in Coronary Flow Reserve (CFR) From 0-6 Months | Primary Efficacy Measure-CFR measured on rest and stress Positron Emission Tomography | 0 to 6 months | |
| Primary | Change in E' on TDI Echo From 0-6 Months | Co-primary efficacy measure measured on Tissue Doppler Echocardiography | 0 to 6 months | |
| Primary | Reduction in Drug Dose or Discontinuation of Study Drug | Primary Tolerability measure | 0 to 6 months | |
| Primary | Number of Patients Completing Study From 0 to 6 Months | Primary Feasibility Measure | 0 to 6 months | |
| Secondary | Change in Circulating Fibrosis Markers and Angiogenesis Markers | Circulating concentrations of markers such as the carboxy terminal of pro-collagen type 1 or ADMA will be measured | 0 to 6 months | |
| Secondary | Change in LVMI | Change in left ventricular mass index between baseline and 6 months. | 0 to 6 months |