| Trial ID: | L1078 |
| Source ID: | NCT01691053
|
| Associated Drug: |
Spironolactone
|
| Title: |
Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
|
| Acronym: |
MiREnDa
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease / Hemodialysis
|
| Interventions: |
DRUG: Spironolactone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Left Ventricular Mass Index, as assessed by cardiac MRI, 9 months | Secondary: Cardiac function parameters, cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography, 9 months|Office and 24h blood pressure, 9 months|Clinical measures of heart failure severity, New York Heart Association (NYHA) functional class, 6 minute walk test, 9 months|Vascular function, Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery, 9 months|Biomarkers of heart failure, inflammation and fibrosis, 9 months|Quality of Life - Hospital Anxiety and Depression Scale (HADS), Quality of life will be measured by analyzing HADS, 9 months|Cardiac death and/or hospitalization for heart failure, 9 months|Safety measures, Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K\>6.5mmol/l), measurement of residual kidney function (if applicable), 9 months|Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36), Quality of life will be measured by analyzing KDQOL-SF36, 9 months
|
| Sponsor/Collaborators: |
Sponsor: Wuerzburg University Hospital | Collaborators: German Federal Ministry of Education and Research|Clinical Trial Center Wuerzburg (CTCW)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
118
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-12
|
| Completion Date: |
2018-03-28
|
| Results First Posted: |
|
| Last Update Posted: |
2019-08-06
|
| Locations: |
University Hospital Erlangen-Nürnberg, Erlangen, 91054, Germany|University Hospital Frankfurt, Frankfurt, 60590, Germany|University Hospital Wuerzburg, Wuerzburg, 97080, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01691053
|
