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NCT Number: NCT01691053

Mineralocorticoid Receptor Antagonists in End Stage Renal Disease

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.

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Key information

Conditions

End Stage Renal Disease / Hemodialysis Cardiomegaly Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Erlangen-Nürnberg, Erlangen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone

Drug

50mg once daily

Placebo

Drug

Placebo

Primary outcomes

  1. Left Ventricular Mass Index

    Time frame: 9 months

    as assessed by cardiac MRI

Secondary outcomes

  1. Cardiac function parameters

    Time frame: 9 months

    cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography

  2. Office and 24h blood pressure

    Time frame: 9 months

  3. Clinical measures of heart failure severity

    Time frame: 9 months

    New York Heart Association (NYHA) functional class, 6 minute walk test

  4. Vascular function

    Time frame: 9 months

    Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery

  5. Biomarkers of heart failure, inflammation and fibrosis

    Time frame: 9 months

  6. Quality of Life - Hospital Anxiety and Depression Scale (HADS)

    Time frame: 9 months

    Quality of life will be measured by analyzing HADS

  7. Cardiac death and/or hospitalization for heart failure

    Time frame: 9 months

  8. 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)

  9. Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36)

    Time frame: 9 months

    Quality of life will be measured by analyzing KDQOL-SF36

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Clinical Trial Center Wuerzburg (CTCW)
  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: MiREnDa

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Sep 24, 2012
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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