Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
- Conditions
- End Stage Renal Disease / Hemodialysis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01691053
- Lead Sponsor
- Wuerzburg University Hospital
- Brief Summary
End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- Age >18 years
- Hemodialysis treatment for at least 3 months
- At least 3 dialysis sessions per week
- Written informed consent
- Contraindications for cardiac magnet resonance imaging (CMR)
- Mineralocorticoid receptor antagonist treatment within the last 6 months
- Estimated life expectancy < 12 months as judged by the nephrologist
- History of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
- High risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l
- Hypotension (systolic blood pressure < 100 mmHg)
- Planned kidney transplantation (living donor) within the prospected study duration
- Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
- Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
- Allergy/hypersensitivity to spironolactone
- Non-compliance suspected or demonstrated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Spironolactone Spironolactone -
- Primary Outcome Measures
Name Time Method Left Ventricular Mass Index 9 months as assessed by cardiac MRI
- Secondary Outcome Measures
Name Time Method Vascular function 9 months Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery
Clinical measures of heart failure severity 9 months New York Heart Association (NYHA) functional class, 6 minute walk test
Office and 24h blood pressure 9 months Quality of Life - Hospital Anxiety and Depression Scale (HADS) 9 months Quality of life will be measured by analyzing HADS
Cardiac death and/or hospitalization for heart failure 9 months Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36) 9 months Quality of life will be measured by analyzing KDQOL-SF36
Cardiac function parameters 9 months cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography
Biomarkers of heart failure, inflammation and fibrosis 9 months Safety measures 9 months Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K\>6.5mmol/l), measurement of residual kidney function (if applicable)
Trial Locations
- Locations (3)
University Hospital Erlangen-Nürnberg
🇩🇪Erlangen, Germany
University Hospital Frankfurt
🇩🇪Frankfurt, Germany
University Hospital Wuerzburg
🇩🇪Wuerzburg, Germany