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A randomized controlled trial of the effect of spironolactone on left ventricular mass in hemodialysis patients.
Hammer, Fabian; Malzahn, Uwe; Donhauser, Julian; Betz, Christoph; Schneider, Markus P; Grupp, Clemens; Pollak, Nils; Störk, Stefan; Wanner, Christoph; Krane, Vera.
Afiliación
  • Hammer F; Department of Medicine I, Division of Cardiology, University Hospital Würzburg, Würzburg, Germany; Comprehensive Heart Failure Center, University and University Hospital Würzburg, Würzburg, Germany; Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany. Electronic ad
  • Malzahn U; Clinical Trial Center, University Hospital Würzburg, Würzburg, Germany.
  • Donhauser J; Department of Diagnostic and Interventional Radiology, University of Würzburg, Würzburg, Germany.
  • Betz C; Medical Clinic III, Department of Nephrology, University Hospital Frankfurt, Frankfurt, Germany.
  • Schneider MP; Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany.
  • Grupp C; Department of Nephrology and Hypertension, Sozialstiftung Bamberg, Bamberg, Germany.
  • Pollak N; Department of Pharmacy, University Hospital Würzburg, Würzburg, Germany.
  • Störk S; Department of Medicine I, Division of Cardiology, University Hospital Würzburg, Würzburg, Germany; Comprehensive Heart Failure Center, University and University Hospital Würzburg, Würzburg, Germany.
  • Wanner C; Comprehensive Heart Failure Center, University and University Hospital Würzburg, Würzburg, Germany; Department of Medicine I, Division of Nephrology, University Hospital Würzburg, Würzburg, Germany.
  • Krane V; Comprehensive Heart Failure Center, University and University Hospital Würzburg, Würzburg, Germany; Department of Medicine I, Division of Nephrology, University Hospital Würzburg, Würzburg, Germany.
Kidney Int ; 95(4): 983-991, 2019 04.
Article en En | MEDLINE | ID: mdl-30712923
Mineralocorticoid receptor antagonists have beneficial effects on left ventricular remodeling, cardiac fibrosis, and arrhythmia in heart failure, but efficacy and safety in dialysis patients is less clear. We evaluated the effect of spironolactone on left ventricular mass (LVM), an independent predictor of all-cause and cardiovascular mortality, in hemodialysis patients. In this placebo-controlled, parallel-group trial, 97 hemodialysis patients (23% female; mean age 60.3 years) were randomized to spironolactone 50 mg once daily (n=50) or placebo (n=47). The primary efficacy endpoint was change in LVM index (LVMi) from baseline to 40 weeks as determined by cardiac magnetic resonance imaging. Safety endpoints were development of hyperkalemia and change in residual renal function. There was no significant change in LVMi in participants randomized to spironolactone compared to placebo (-2.86±11.87 vs. 0.41±10.84 g/m2). There was also no difference in the secondary outcomes of mean 24-hour systolic or diastolic ambulatory blood pressure, left ventricular ejection fraction, 6-minute walk test distance, or New York Heart Association functional class. Moderate hyperkalemia (pre-dialysis potassium levels of 6.0-6.5 mmol/L) was more frequent with spironolactone treatment (155 vs. 80 events), but severe hyperkalemia (≥6.5 mmol/L) was not (14 vs. 24 events). Changes in residual urine volume and measured glomerular filtration rate did not differ between groups. There were no deaths in the spironolactone group and 4 deaths in the placebo group. Thus, treatment with 50 mg spironolactone did not change left ventricular mass index, cardiac function, or blood pressure in hemodialysis patients. Spironolactone increased the frequency of moderate hyperkalemia, but did not increase severe hyperkalemia.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Espironolactona / Remodelación Ventricular / Antagonistas de Receptores de Mineralocorticoides / Insuficiencia Cardíaca / Ventrículos Cardíacos Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Kidney Int Año: 2019 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Espironolactona / Remodelación Ventricular / Antagonistas de Receptores de Mineralocorticoides / Insuficiencia Cardíaca / Ventrículos Cardíacos Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Kidney Int Año: 2019 Tipo del documento: Article