Pharmacological blockade of the mineralocorticoid receptor in dialysis patients.

Phase 1

• Conditions: Hemodialysis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-003179-12-DE
• Lead Sponsor: niversity Hospital of Wuerzburg, Medical Director

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-02
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.