Phase
Condition
N/ATreatment
Placebo
Spironolactone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent.
- Adult men and women on HD for at least 45 days for ESRD regardless of the etiologyincluding diabetes, with at least 3 HD sessions per week
- Presenting at least one of the follow comorbidities, cardiovascular abnormalities orCV risk factors:
- Left ventricular hypertrophy defined by left ventricular mass > 130 g/m2 in men and 100 g/m2 in women (echocardiography)
- OR Cornell (RaVL + SV3) >28 mm in men, > 20 mm in women(ECG)
- OR left ventricular ejection fraction < 40%
- OR large QRS > 0.14 sec
- OR Left bundle branch block (ECG) measured during the twelve months precedinginclusion; diabetes;
- OR history of cardiovascular disease: coronary artery disease, symptomatic lower limbperipheral arterial disease, carotid or renal artery stenosis > 50%, stroke,hospitalization for heart failure, permanent atrial fibrillation (AF), oralanticoagulant treatment for AF, valvular heart prosthesis,
- OR CRP > 5 mg/l for 3 months without infectious or neoplastic disease documented inprogress
Exclusion
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 renininhibitor (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 thediscretion 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, apotassium supplements, AINS or Cox 2 inhibitors
Study Design
Study Description
Connect with a study center
Hôpital Erasme- Bruxelles
Bruxelles, 1070
BelgiumSite Not Available
CH Ardeche Nord
Annonay, Ardeche 07100
FranceSite Not Available
CHU Amiens
Amiens, 80054
FranceSite Not Available
CH Avignon
Avignon, 84000
FranceSite Not Available
CHU Besançon
Besançon, 25000
FranceSite Not Available
CHU Bordeaux
Bordeaux, 33076
FranceSite Not Available
CH Boulogne Sur Mer
Boulogne Sur Mer, 62321
FranceSite Not Available
CHRU Brest
Brest, 29609
FranceSite Not Available
CHU Caen
Caen, 14033
FranceSite Not Available
CH Cahors
Cahors, 46000
FranceSite Not Available
CHLM Castelneau
Castelneau Le Lez, 34170
FranceSite Not Available
CH Chambéry
Chambéry, 73000
FranceSite Not Available
CHPC Cherbourg
Cherbourg, 50100
FranceSite Not Available
AURAL Colmar
Colmar, 68000
FranceSite Not Available
Hopitaux Civils de Colmar
Colmar, 68024
FranceSite Not Available
APHP Henri Mondor
Créteil, 94010
FranceSite Not Available
CHU Dijon Hôpital du Bocage
Dijon, 21079
FranceSite Not Available
AGDUC Grenoble
Grenoble, 38043
FranceSite Not Available
AURAL Haguenau
Haguenau, 67500
FranceSite Not Available
CH Haguenau
Haguenau, 67500
FranceSite Not Available
La Roche Sur Yon
La Roche Sur Yon, 85000
FranceSite Not Available
Polyclinique de Lagny
Lagny, 77400
FranceSite Not Available
CHU Lille
Lille, 59037
FranceSite Not Available
Clinique Lille
Lille, 59000
FranceSite Not Available
ALURAD Limoges
Limoges, 87000
FranceSite Not Available
CHU Limoges
Limoges, 87042
FranceSite Not Available
CHG Lisieux
Lisieux, 14100
FranceSite Not Available
AURAL La Croix Rousse
Lyon, 69004
FranceSite Not Available
AURAL Lyon
Lyon, 69008
FranceSite Not Available
CH St Joseph-St Luc
Lyon, 69007
FranceSite Not Available
CHU de Lyon
Lyon, 69003
FranceSite Not Available
APHM Marseille
Marseille, 13385
FranceSite Not Available
Adpc Marseille
Marseille, 13009
FranceSite Not Available
Clinique Bouchard
Marseille, 13006
FranceSite Not Available
Clinique du pont Allant
Maubeuge, 59604
FranceSite Not Available
ALTIR Metz
Metz, 58085
FranceSite Not Available
Association de Metz
Metz, 57000
FranceSite Not Available
CHR Metz-Thionville
Metz, 58085
FranceSite Not Available
AURAL Mulhouse
Mulhouse, 68100
FranceSite Not Available
CH Mulhouse
Mulhouse, 68100
FranceSite Not Available
CHU Nancy
Nancy, 54500
FranceSite Not Available
CHU Nantes
Nantes, 44093
FranceSite Not Available
CHU Nice
Nice, 06002
FranceSite Not Available
Clinique St Georges
Nice, 06100
FranceSite Not Available
CHU Nîmes
Nîmes, 30029
FranceSite Not Available
AP-HP La Salpêtrière
Paris, 75013
FranceSite Not Available
AP-HP Necker
Paris, 75743
FranceSite Not Available
AURA Paris 14ème
Paris, 75014
FranceSite Not Available
AURA Paris Plaisance
Paris, 75014
FranceSite Not Available
Hôpital Tenon
Paris, 75020
FranceSite Not Available
Institut Mutualiste Montsouris
Paris,
FranceSite Not Available
CHU Lyon Sud
Pierre-Bénite, 69495
FranceSite Not Available
AUB Morlaix
Plourin Lès Morlaix, 29600
FranceSite Not Available
ARPDD Reims
Reims, 51726
FranceSite Not Available
CHU de Reims
Reims, 51100
FranceSite Not Available
CHU Rennes
Rennes, 35000
FranceSite Not Available
ECHO Confluent
Reze, 44402
FranceSite Not Available
Centre de Perharidy
Roscoff, 29260
FranceSite Not Available
CH Roubaix
Roubaix, 59056
FranceSite Not Available
CHU Rouen
Rouen, 76031
FranceSite Not Available
CHU de la Réunion Hôpital Félix Guyon
Saint Denis, 97405
FranceSite Not Available
CH Mémorial Saint Lô
Saint Lô, 50000
FranceSite Not Available
Aub Saint Malo
Saint Malo, 35400
FranceSite Not Available
Ch Saint Malo
Saint-Malo, 35403
FranceSite Not Available
CHG St Brieuc
St Brieuc, 22000
FranceSite Not Available
Nephrocare Tassin-Charcot
St Foy-les-lyon, 69110
FranceSite Not Available
CH St Maurice
St Maurice, 94410
FranceSite Not Available
Clinique St Ouen
St Ouen, 93400
FranceSite Not Available
AURAL St Anne (AURAL Strasbourg)
Strasbourg, 67000
FranceSite Not Available
AURAL Strasbourg
Strasbourg, 67200
FranceSite Not Available
CHU Strasbourg
Strasbourg, 67000
FranceSite Not Available
Clinique Sainte Anne
Strasbourg, 67000
FranceSite Not Available
CHU Toulouse
Toulouse, 31059
FranceSite Not Available
CHU Tours
Tours, 37000
FranceSite Not Available
CH Troyes
Troyes, 10003
FranceSite Not Available
CH Valence
Valence, 26000
FranceSite Not Available
CH Valenciennes
Valenciennes, 59322
FranceSite Not Available
ALTIR Nancy
Vandoeuvre les Nancy, 54504
FranceSite Not Available
Hôpitaux Privés de Metz- Hôpital Robert Schuman
Vantoux, 57070
FranceSite Not Available
CH Verdun
Verdun, 55107
FranceSite Not Available
CH Vichy
Vichy, 03201
FranceSite Not Available
Clinique de Choisy
Gosier, 97190
GuadeloupeSite Not Available
Hopital du Lamentin Martinique
Le Lamentin, 97232
MartiniqueSite Not Available
CH Princesse Grace
Monaco,
MonacoSite Not Available
CHU Vaudois
Lausanne,
SwitzerlandSite Not Available
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