| Trial ID: | L1518 |
| Source ID: | NCT02228408
|
| Associated Drug: |
Hydralazine/Isorsorbide Dinitrate
|
| Title: |
Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD
|
| Acronym: |
HIDE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02228408/results
|
| Conditions: |
Chronic Hemodialysis (ESRD)
|
| Interventions: |
DRUG: Hydralazine/Isorsorbide Dinitrate|DRUG: Placebo
|
| Outcome Measures: |
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|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|Change in E' on TDI Echo From 0-6 Months, Co-primary efficacy measure measured on Tissue Doppler Echocardiography, 0 to 6 months|Reduction in Drug Dose or Discontinuation of Study Drug, Primary Tolerability measure, 0 to 6 months|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|Change in LVMI, Change in left ventricular mass index between baseline and 6 months., 0 to 6 months
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
17
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2017-08-28
|
| Completion Date: |
2019-05-07
|
| Results First Posted: |
2021-04-27
|
| Last Update Posted: |
2021-04-27
|
| Locations: |
Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02228408
|
