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Mineralocorticoid Receptor Antagonists in End Stage Renal Disease

Information source: Wuerzburg University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Disease / Hemodialysis

Intervention: Spironolactone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Wuerzburg University Hospital

Official(s) and/or principal investigator(s):
Christoph Wanner, MD, Principal Investigator, Affiliation: University Hospital Wuerzburg
Fabian Hammer, MD, PhD, Principal Investigator, Affiliation: University Hospital Wuerzburg

Overall contact:
Fabian Hammer, MD, PhD, Phone: +49931201, Ext: 46380, Email: hammer_f@klinik.uni-wuerzburg.de


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.

Clinical Details

Official title: Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Left Ventricular Mass Index

Secondary outcome:

Cardiac function parameters

Office and 24h blood pressure

Clinical measures of heart failure severity

Vascular function

Biomarkers of heart failure, inflammation and fibrosis

Quality of Life

Cardiac death and/or hospitalization for heart failure

Safety measures


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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,


- Allergy/hypersensitivity to spironolactone

- Non-compliance suspected or demonstrated

Locations and Contacts

Fabian Hammer, MD, PhD, Phone: +49931201, Ext: 46380, Email: hammer_f@klinik.uni-wuerzburg.de

University Hospital Erlangen-Nürnberg, Erlangen 91054, Germany; Active, not recruiting

University Hospital Frankfurt, Frankfurt 60590, Germany; Recruiting
Helmut Geiger, MD, Phone: +49696301, Ext: 5555, Email: h.geiger@em.uni-frankfurt.de
Christoph Betz, MD, Phone: +49696301, Ext: 7495, Email: C.Betz@em.uni-frankfurt.de
Helmut Geiger, MD, Principal Investigator
Christoph Betz, MD, Sub-Investigator

University Hospital Wuerzburg, Wuerzburg 97080, Germany; Active, not recruiting

Additional Information

Starting date: December 2012
Last updated: February 14, 2014

Page last updated: August 23, 2015

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