Last updated on December 2018

ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial


Brief description of 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.

Detailed Study Description

  • During a run-in period : Spironolactone will be initially administered per os at a 25 mg dose per two days in practice after the session, three times per week
    • Patients will be randomized (spironolactone vs. placebo) and titrated over one month to a maximum single dose of 25 mg/d
    • However if kalemia is greater than or equal to 5.5 mmol / l twice on this run-in period or on the day of randomization, patient won't be randomized.
    • A pre-specified algorithm for the management of the risk of incident hyperkalemia will be followed, including dose adjustment, temporary cessation of study treatment, in addition to usual dietary measures and the use of chelating resins and low-potassium dialysis baths
    • Patients will be followed for a mean of 2 years.

Clinical Study Identifier: NCT01848639

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Adpc Marseille

Marseille, France
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Aub Saint Malo

Saint Malo, France
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CHU Amiens

Amiens, France
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CH Avignon

Avignon, France
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CHU Bordeaux

Bordeaux, France
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CH Boulogne Sur Mer

Boulogne Sur Mer, France
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Cahors, France
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Cherbourg, France
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CH Haguenau

Haguenau, France
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La Roche Sur Yon

La Roche Sur Yon, France
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Lille, France
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CHU Limoges

Limoges, France
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CHG Lisieux

Lisieux, France
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APHM Marseille

Marseille, France
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CH Mulhouse

Mulhouse, France
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CHU Nancy

Nancy, France
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CHU Nantes

Nantes, France
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AUB Rennes

Rennes, France
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CHU Rennes

Rennes, France
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CH Roubaix

Roubaix, France
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Ch Saint Malo

Saint-Malo, France
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CHG St Brieuc

St Brieuc, France
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CH St Maurice

St Maurice, France
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CHU Strasbourg

Strasbourg, France
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AURAL Strasbourg

Strasbourg, France
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CHU Toulouse

Toulouse, France
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CHU Tours

Tours, France
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CH Troyes

Troyes, France
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CH Valenciennes

Valenciennes, France
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ALTIR Nancy

Vandoeuvre les Nancy, France
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CH Verdun

Verdun, France
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CH Vichy

Vichy, France
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CHU Besan on

Besançon, France
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CH Chamb ry

Chambéry, France
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CHU Lyon Sud

Pierre-Bénite, France
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Recruitment Status: Open


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