Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed,
and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government
operating status and resumption of normal operations can be found at opm.gov.
Mineralocorticoid Receptor Antagonists in End Stage Renal Disease (MiREnDa)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age >18 years
Hemodialysis treatment for at least 3 months
At least 3 dialysis sessions per week
Written informed consent
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