Completed

MiREnDaSpironolactone for Cardioprotection in Hemodialysis Patients with End Stage Renal Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Spironolactone

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+16

+ Cardiovascular Diseases

+ Chronic Disease

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorWuerzburg University Hospital
Last updated: August 6, 2019
Sourced from a government-validated database.Claim as a partner

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.

NCT01691053
Principal SponsorWuerzburg University Hospital
Last updated: August 6, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

118 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesCardiovascular DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsHeart DiseasesCardiomegalyHypertrophyKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesPathological Conditions, AnatomicalDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesKidney Failure, ChronicHypertrophy, Left Ventricular

Criteria

4 inclusion criteria required to participate
Age > 18 years

At least 3 dialysis sessions per week

Hemodialysis treatment for at least 3 months

Written informed consent

11 exclusion criteria prevent from participating
Allergy/hypersensitivity to spironolactone

Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist

Contraindications for cardiac magnet resonance imaging (CMR)

Estimated life expectancy < 12 months as judged by the nephrologist

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study 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 Maps

University Hospital Frankfurt

Frankfurt, Germany

University Hospital Wuerzburg

Würzburg, Germany
Completed3 Study Centers