A Phase 3 interventional study of Spironolactone and Placebo in End Stage Renal Failure on Dialysis, sponsored by University Hospital, Brest. Completed at 70 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by University Hospital, Brest · Phase 3, Interventional, and Treatment
This study is designed to etablish the effects of spironolactone in comparison to placebo on the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The primary endpoint will be the time to onset of the first incident.
Exclusion Criteria:
After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to spironolactone. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.
Drug: Spironolactone
After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to placebo. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.
Drug: Placebo
After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to spironolactone. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.
After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to placebo. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.
The time to onset of the first incident :non-fatal MI or acute coronary syndrome or hospitalization for heart failure or nonfatal stroke or cardiovascular (CV) death
Time frame: 25 months
Determine the effects of spironolactone compared to placebo on the composite winratio endpoint
Following a hierarchical strategy of statistical tests including the primary endpoint. Composite winratio endpoint of: all-cause mortality at 2 years according to the Finkelstein and Schoenfeld method.
Time frame: 24 months
Determine the effects of spironolactone compared to placebo on the composite winratio endpoint
Following a hierarchical strategy of statistical tests including the primary endpoint. Composite winratio endpoint of: time until a cardiovascular event (hospitalization for heart failure, or non-fatal myocardial infarction, or acute coronary syndrome or non-fatal stroke) at 2 years according to the Finkelstein and Schoenfeld method.
Time frame: 24 months
non-cardiovascular mortality rate
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
cumulative accident rates forming the primary endpoint
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
The time of survival without a major CV event (non fatal MI, acute coronary syndrome, hospitalization for heart failure, non-fatal stroke, cardiac arrest resuscitation)
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
Incidence of procedures related to stenosis or vascular access thrombosis for hemodialysis (HD)
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
Incidence of coronary or peripheral revascularizations (including lower limb amputations)
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
Blood pressure (systolic and diastolic pressure)
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
Blood pressure's variability inter visit (systolic and diastolic pressure)
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
The occurrence of atrial fibrillation
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
Incidence of hyperkalemia> 6 mmol/l
Additional secondary objectives will be considered in the context of hypothesis generation
Time frame: 24 months
Estimation of the effect of treatment on quality of life.
KDQoL questionnaire ; minimum value = 0 ; maximum value = 100 ; higher score means a better outcome
Time frame: 24 months
Estimation of the effect of treatment on quality of life.
Minnesota questionnaire ; minimum value = 0 ; maximum value = 100 ; higher score means a better outcome
Time frame: 24 months
Estimation of the effect of treatment on quality of life.
SF36 questionnaire ; minimum value = 0 ; maximum value = 100 ; higher score means a better outcome
Time frame: 24 months
Ancillary study:establishment of a biological collection (serum bank and DNA biobank) for future biomarker studies
Time frame: 24 months
Ancillary study:morbimortality data
Time frame: 3, 5 and 10 years of follow-up after the double-blind study
Plan to share: Yes — Statistical Analysis Plan
Supporting information: Sap
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest