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Mineralocorticoid Receptor Antagonists in End Stage Renal Disease (MiREnDa)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Wuerzburg University Hospital.
Recruitment status was:  Active, not recruiting
German Federal Ministry of Education and Research
Clinical Trial Center Wuerzburg (CTCW)
Information provided by (Responsible Party):
Wuerzburg University Hospital Identifier:
First received: September 19, 2012
Last updated: November 2, 2016
Last verified: February 2014
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.

Condition Intervention Phase
End Stage Renal Disease / Hemodialysis Drug: Spironolactone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients

Resource links provided by NLM:

Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • Left Ventricular Mass Index [ Time Frame: 9 months ]
    as assessed by cardiac MRI

Secondary Outcome Measures:
  • Cardiac function parameters [ Time Frame: 9 months ]
    cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography

  • Office and 24h blood pressure [ Time Frame: 9 months ]
  • Clinical measures of heart failure severity [ Time Frame: 9 months ]
    New York Heart Association (NYHA) functional class, 6 minute walk test

  • Vascular function [ Time Frame: 9 months ]
    Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery

  • Biomarkers of heart failure, inflammation and fibrosis [ Time Frame: 9 months ]
  • Quality of Life [ Time Frame: 9 months ]
  • Cardiac death and/or hospitalization for heart failure [ Time Frame: 9 months ]
  • Safety measures [ Time Frame: 9 months ]
    Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K>6.5mmol/l), measurement of residual kidney function (if applicable)

Enrollment: 118
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spironolactone Drug: Spironolactone
50mg once daily
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01691053

University Hospital Erlangen-Nürnberg
Erlangen, Germany, 91054
University Hospital Frankfurt
Frankfurt, Germany, 60590
University Hospital Wuerzburg
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
German Federal Ministry of Education and Research
Clinical Trial Center Wuerzburg (CTCW)
Principal Investigator: Christoph Wanner, MD University Hospital Wuerzburg
Principal Investigator: Fabian Hammer, MD, PhD University Hospital Wuerzburg
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wuerzburg University Hospital Identifier: NCT01691053     History of Changes
Other Study ID Numbers: MN0511_1
2011-003179-12 ( EudraCT Number )
01KG1202 ( Other Grant/Funding Number: German Ministry of Education and Research )
Study First Received: September 19, 2012
Last Updated: November 2, 2016

Keywords provided by Wuerzburg University Hospital:
End stage renal disease
Left ventricular hypertrophy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Hormones processed this record on September 25, 2017