MiREnDaSpironolactone for Cardioprotection in Hemodialysis Patients with End Stage Renal Disease
Spironolactone
+ Placebo
Urogenital Diseases+16
+ Cardiovascular Diseases
+ Chronic Disease
Treatment Study
Summary
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.Patients with end stage renal disease (ESRD) often face high mortality rates, with nearly half of these cases caused by cardiovascular issues. A common condition in ESRD patients undergoing dialysis is increased left ventricular mass (LVM), which independently predicts survival. Currently, there's no established medical treatment to decrease cardiovascular morbidity and mortality in ESRD patients on hemodialysis. This study explores the potential of a mineralocorticoid receptor antagonist (MRA) called spironolactone. This drug has shown promise in heart failure patients and has recently been found to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The researchers believe that spironolactone treatment could protect the heart by reducing LVM in ESRD patients on dialysis. This phase 2 interventional trial aims to evaluate the efficacy and safety of spironolactone in hemodialysis patients. Participants will receive spironolactone treatment, and the study will measure its impact on the left ventricular mass index. This will be assessed using cardiac MRI, a non-invasive imaging technique that provides detailed pictures of the heart. The primary outcome of the study is to determine if spironolactone can reduce the left ventricular mass index in these patients, potentially offering a new treatment option for this high-risk population.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.118 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
University Hospital Erlangen-Nürnberg
Erlangen, GermanyOpen University Hospital Erlangen-Nürnberg in Google MapsUniversity Hospital Frankfurt
Frankfurt, GermanyUniversity Hospital Wuerzburg
Würzburg, Germany