Hemodialysis
Conditions
Interventions
Trade Name: Spironolacton Hexal ®
Product Name: Spironolactone
Pharmaceutical Form: Tablet
INN or Proposed INN: SPIRONOLACTONE
CAS Number: 52-01-7
Concentration unit: mg milligram(s)
Concentration num
Sponsors
University Hospital of Wuerzburg, Medical Director
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent Age > 18 years Hemodialysis treatment for at least 3 months At least 3 dialysis sessions per week Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Contraindications for cardiac magnet resonance imaging (CMR) Mineralocorticoid receptor antagonist treatment within the last 6 months Estimated life expectancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of the mineralocorticoid receptor antagonist spironolactone on left ventricular mass index in end stage renal disease patients on hemodialysis.;Secondary Objective: To investigate the effect of spironolactone treatment on the following parameters/outcomes: cardiac function, serum potassium levels, blood pressure, hospitalization or death due to heart failure, kidney function, heart rate variability, cardiac arrhythmias, exercise capacity (6-minute walk test), vascular function (pulse wave analysis, flow-mediated dilatation, carotid intima-media thickness, carotid artery distensibility), body composition, quality of life and cardiovascular biomarkers, retinal capillary blood flow, retinal arteriolar wall structure;Primary end point(s): Change in left ventricular mass index (LVMi) measured by cardiac MRI;Timepoint(s) of evaluation of this end point: Baseline, after 9 months treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cardiac function parameters (cardiac volumes, systolic and diastolic function, cardiac output) measured by CMR and echocardiography Pre-dialysis serum potassium levels Frequency of hyperkalemic episodes (potassium = 6.5 mmol/l) Office and 24h blood pressure Clinical measures of heart failure severity (New York Heart Association (NYHA) functional class, 6 minute walk test) Cardiac death and/or hospitalization due to heart failure (combined endpoint) Residual kidney function (urine volume, creatinine-, urea-clearance, electrolyte excretion) Heart rate variability (ECG) Arterial stiffness (pulse wave analysis (PWA)) Carotid intima media thickness (CIMT) Carotid artery distensibility (CD) Flow-mediated dilatation (FMD) of the brachial artery Body composition (bioimpedance spectroscopy) Biomarkers of fibrosis, inflammation and heart failure Quality of life Adherence to study medication retinal capillary blood flow, retinal arteriolar wall structure (scanning laser Doppler flowmetry);Timepoint(s) of evaluation of this end point: after a treatment duration of 9 months | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information Desk
University Hospital of Wuerzburg
Outcome results
None listed