Mineralocorticoid Receptor Antagonists in End Stage Renal Disease (MiREnDa)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Wuerzburg University Hospital
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Clinical Trial Center Wuerzburg (CTCW)
Information provided by (Responsible Party):
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01691053
First received: September 19, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    as assessed by cardiac MRI


Secondary Outcome Measures:
  • Cardiac function parameters [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography

  • Office and 24h blood pressure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Clinical measures of heart failure severity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    New York Heart Association (NYHA) functional class, 6 minute walk test

  • Vascular function [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Cardiac death and/or hospitalization for heart failure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Safety measures [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K>6.5mmol/l), measurement of residual kidney function (if applicable)


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spironolactone Drug: Spironolactone
50mg once daily
Placebo Comparator: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691053

Contacts
Contact: Fabian Hammer, MD, PhD +49931201 ext 46380 hammer_f@klinik.uni-wuerzburg.de
Contact: Christoph Wanner, MD +49931201 ext 39030 wanner_c@klinik.uni-wuerzburg.de

Locations
Germany
University Hospital Erlangen-Nürnberg Active, not recruiting
Erlangen, Germany, 91054
University Hospital Frankfurt Recruiting
Frankfurt, Germany, 60590
Contact: Helmut Geiger, MD    +49696301 ext 5555    h.geiger@em.uni-frankfurt.de   
Contact: Christoph Betz, MD    +49696301 ext 7495    C.Betz@em.uni-frankfurt.de   
Principal Investigator: Helmut Geiger, MD         
Sub-Investigator: Christoph Betz, MD         
University Hospital Wuerzburg Active, not recruiting
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
German Federal Ministry of Education and Research
Clinical Trial Center Wuerzburg (CTCW)
Investigators
Principal Investigator: Christoph Wanner, MD University Hospital Wuerzburg
Principal Investigator: Fabian Hammer, MD, PhD University Hospital Wuerzburg
  More Information

No publications provided by Wuerzburg University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01691053     History of Changes
Other Study ID Numbers: MN0511_1, 2011-003179-12, 01KG1202
Study First Received: September 19, 2012
Last Updated: February 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Mineralocorticoids
Spironolactone
Aldosterone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormone Antagonists
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014