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Mineralocorticoid Receptor Antagonists in End Stage Renal Disease

NCT01691053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2019-08-06

No results posted yet for this study

Summary

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.

Conditions

  • End Stage Renal Disease / Hemodialysis

Interventions

DRUG

Spironolactone

50mg once daily

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Clinical Trial Center Wuerzburg (CTCW)

    collaborator UNKNOWN

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Christoph Wanner, MD · University Hospital Wuerzburg

  • Fabian Hammer, MD, PhD · University Hospital Wuerzburg

  • Vera Krane, MD · University Hospital Wuerzburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-02-14
Completion
2018-03-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691053 on ClinicalTrials.gov