End Stage Renal Disease / Hemodialysis | Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
End Stage Renal Disease / Hemodialysis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Age >18 years - Hemodialysis treatment for at least 3 months - At least 3 dialysis sessions per week - Written informed consent 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
End Stage Renal Disease / Hemodialysis
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Spironolactone50mg once daily
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: December 2012
Completed Date: December 2016
Phase: Phase 2
Primary Outcome: Left Ventricular Mass Index
Secondary Outcome: Cardiac function parameters
Study sponsors, principal investigator, and references
Principal Investigator: Christoph Wanner, MD
Lead Sponsor: Wuerzburg University Hospital
Collaborator: German Federal Ministry of Education and Research