PatientsVille.com LogoPatientsVille.com

End Stage Renal Failure on Dialysis | ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

End Stage Renal Failure on Dialysis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Written informed consent - Health insurance beneficiary - Men and women, on hemodialysis for at least 45 days for end-stage renal disease regardless of the aetiology including diabetes, with at least 3 hemodialysis sessions per week AND presenting at least one of following comorbidities or CV risk factors: - left ventricular mass > 130 g/m2 in men and 100 g/m2 in women measured during the twelve months preceding inclusion - left ventricular ejection fraction < 40% measured during the twelve months preceding inclusion - diabetes - history of Cardiovascular disease: coronary artery disease, symptomatic lower limb peripheral arterial disease, carotid or renal artery stenosis > 50%, stroke, hospitalization for heart failure or CRP> 5 mg / l for 3 months without infectious or neoplastic disease documented in progress Exclusion Criteria: - history of hypersensitivity to spironolactone or galactose intolerance - the Lapp lactase deficiency or malabsorption of glucose or galactose - hyperkalemia > 5.5 mmol/l during the two weeks prior to enrolment - history of unscheduled hemodialysis for hyperkalemia during the last six months - hospitalization for hyperkalemia during the last six months - patients with imperative indication of a combination of ACEI and sartan or renin inhibitor (each being authorized separately), NSAIDS, Cox-2 inhibitors - kidney transplant scheduled within the year - symptomatic interdialytic hypotension - acute systemic disease - uncompensated hypothyroidism - acute hyperthyroidism - any prior or concomitant clinical condition compromising the inclusion, in the discretion of the investigator - cardiac transplant - severe uncontrolled arrhythmia - stroke within 3 months prior to enrolment - acute coronary syndrome in the previous month inclusion - recent (1 month) or planned coronary revascularization by angioplasty - recent (3 months) or planned cardiovascular surgery (excluding HD vascular access) - non menopausal women or without effective contraceptive methods - pregnancy, breastfeeding or planning a pregnancy within 2 years - non compliance - protected adult - SBP > 200 mmHg and/or DBP > 110 mmHg - Concomitant treatment can not be stopped by another potassium-sparing diuretic, a potassium supplements, AINS or Cox 2 inhibitors

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

End Stage Renal Failure on Dialysis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SpironolactoneAfter 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:PlaceboAfter 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SpironolactoneAfter 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.

PlaceboAfter 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.

Study Status

Recruiting

Start Date: June 2013

Completed Date: June 2024

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 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

Secondary Outcome: The cumulate rate of non fatal MI or acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or CV death

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University Hospital, Brest

Collaborator: Central Hospital, Nancy, France

More information:https://clinicaltrials.gov/show/NCT01848639

Discuss Spironolactone