| Outcome Measures: |
Primary: 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, 25 months | Secondary: 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., 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., 24 months|non-cardiovascular mortality rate, Additional secondary objectives will be considered in the context of hypothesis generation, 24 months|cumulative accident rates forming the primary endpoint, Additional secondary objectives will be considered in the context of hypothesis generation, 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, 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, 24 months|Incidence of coronary or peripheral revascularizations (including lower limb amputations), Additional secondary objectives will be considered in the context of hypothesis generation, 24 months|Blood pressure (systolic and diastolic pressure), Additional secondary objectives will be considered in the context of hypothesis generation, 24 months|Blood pressure's variability inter visit (systolic and diastolic pressure), Additional secondary objectives will be considered in the context of hypothesis generation, 24 months|The occurrence of atrial fibrillation, Additional secondary objectives will be considered in the context of hypothesis generation, 24 months|Incidence of hyperkalemia> 6 mmol/l, Additional secondary objectives will be considered in the context of hypothesis generation, 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, 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, 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, 24 months | Other: Ancillary study:establishment of a biological collection (serum bank and DNA biobank) for future biomarker studies, 24 months|Ancillary study:morbimortality data, 3, 5 and 10 years of follow-up after the double-blind study
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| Locations: |
Hôpital Erasme- Bruxelles, Bruxelles, 1070, Belgium|CH Ardeche Nord, Annonay, Ardeche, 07100, France|CHU Amiens, Amiens, 80054, France|CH Avignon, Avignon, 84000, France|CHU Besançon, Besançon, 25000, France|CH Boulogne Sur Mer, Boulogne Sur Mer, 62321, France|CHRU Brest, Brest, 29609, France|CHU Caen, Caen, 14033, France|CH Cahors, Cahors, 46000, France|CH Chambéry, Chambéry, 73000, France|CHPC Cherbourg, Cherbourg, 50100, France|AURAL Colmar, Colmar, 68000, France|Hopitaux Civils de Colmar, Colmar, 68024, France|APHP Henri Mondor, Créteil, 94010, France|CHU Dijon Hôpital du Bocage, Dijon, 21079, France|AGDUC Grenoble, Grenoble, 38043, France|AURAL Haguenau, Haguenau, 67500, France|CH Haguenau, Haguenau, 67500, France|La Roche Sur Yon, La Roche Sur Yon, 85000, France|Polyclinique de Lagny, Lagny, 77400, France|Clinique Lille, Lille, 59000, France|CHU Lille, Lille, 59037, France|ALURAD Limoges, Limoges, 87000, France|CHU Limoges, Limoges, 87042, France|CHU de Lyon, Lyon, 69003, France|AURAL La Croix Rousse, Lyon, 69004, France|CH St Joseph-St Luc, Lyon, 69007, France|AURAL Lyon, Lyon, 69008, France|Clinique Bouchard, Marseille, 13006, France|Adpc Marseille, Marseille, 13009, France|APHM Marseille, Marseille, 13385, France|Association de Metz, Metz, 57000, France|ALTIR Metz, Metz, 58085, France|CHR Metz-Thionville, Metz, 58085, France|AURAL Mulhouse, Mulhouse, 68100, France|CH Mulhouse, Mulhouse, 68100, France|CHU Nancy, Nancy, 54500, France|CHU Nantes, Nantes, 44093, France|CHU Nice, Nice, 06002, France|Clinique St Georges, Nice, 06100, France|AP-HP La Salpêtrière, Paris, 75013, France|AURA Paris 14ème, Paris, 75014, France|AURA Paris Plaisance, Paris, 75014, France|Hôpital Tenon, Paris, 75020, France|AP-HP Necker, Paris, 75743, France|Institut Mutualiste Montsouris, Paris, France|CHU Lyon Sud, Pierre-Bénite, 69495, France|CHU de Reims, Reims, 51100, France|ARPDD Reims, Reims, 51726, France|CHU Rennes, Rennes, 35000, France|ECHO Confluent, Reze, 44402, France|Centre de Perharidy, Roscoff, 29260, France|CH Roubaix, Roubaix, 59056, France|CHU de la Réunion Hôpital Félix Guyon, Saint Denis, 97405, France|Aub Saint Malo, Saint Malo, 35400, France|Ch Saint Malo, Saint-Malo, 35403, France|CHG St Brieuc, St Brieuc, 22000, France|AURAL St Anne (AURAL Strasbourg), Strasbourg, 67000, France|CHU Strasbourg, Strasbourg, 67000, France|Clinique Sainte Anne, Strasbourg, 67000, France|AURAL Strasbourg, Strasbourg, 67200, France|CHU Toulouse, Toulouse, 31059, France|CHU Tours, Tours, 37000, France|CH Troyes, Troyes, 10003, France|CH Valenciennes, Valenciennes, 59322, France|ALTIR Nancy, Vandoeuvre les Nancy, 54504, France|Hôpitaux Privés de Metz- Hôpital Robert Schuman, Vantoux, 57070, France|CH Verdun, Verdun, 55107, France|CH Vichy, Vichy, 03201, France|CH Princesse Grace, Monaco, Monaco
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