| Trial ID: | L1126 |
| Source ID: | NCT01855334
|
| Associated Drug: |
Spironolactone
|
| Title: |
L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD
|
| Acronym: |
LAST-D
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Hemodialysis
|
| Interventions: |
DRUG: Spironolactone|DIETARY_SUPPLEMENT: L-arginine|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in coronary Flow Reserve (PET), Coronary flow reserve will be measured using rest and stress 13N ammonia myocardial positron emission tomography (PET) at baseline and 9 months, Between baseline and 9 months|Change in left ventricular diastolic function, Left ventricular diastolic function will be measured using mitral annular E' on tissue doppler index echocardiography at baseline and 9 months, Between baseline and 9 months | Secondary: Association between coronary flow reserve (CFR) and tissue doppler index (E'), Baseline|Change in resting myocardial blood flow, Between baseline and 9 months|Change in left ventricular mass index, Between baseline and 9 months|Change in coronary vascular resistance, Between 0 and 9 months|Association between change in coronary flow reserve (CFR) and change in diastolic function-tissue doppler index (E'), Between baseline and 9 months|Change in early diastolic function (E'), Between baseline and 2 weeks|Combined cardiovascular safety, Combined rate of death, myocardial infarction, stroke, or hospitalization, Up to 9 months|Cardiovascular death, Up to 9 months|Hyperkalemia, Hyperkalemia requiring extra dialysis, adjustment in dialysate potassium, or discontinuation of therapy, Up to 9 months|Hypotension, Symptomatic or intradialytic hypotension up to 9 months, Up to 9 months|Change in early coronary flow reserve, Between baseline and 2 weeks|Change in hyperemic myocardial blood flow, Between baseline and 9 months
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital | Collaborators: Massachusetts General Hospital|Beth Israel Deaconess Medical Center|Joslin Diabetes Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-09
|
| Completion Date: |
2018-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-05-04
|
| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 021114, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02120, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01855334
|
