A randomized controlled trial of the effect of spironolactone on left ventricular mass in hemodialysis patients
| Autor: | Sebastian Toncar, Thomas Schmiedeke, Thomas Vogl, Nils Pollak, Michael Leidig, Beatrix Büschges-Seraphin, Marianne Kleinert, Cord Schneuzer, Christina Klaeffling, Clemens Grupp, Christoph Blaser, Susanne Berweck, Rüdiger Götz, Stefan Fischer, Andreas Schmitt, Bettina Wirth, Frank Breunig, Markus Ketteler, Hendrick Witsch, Frank Strutz, Uwe Malzahn, Oliver Jung, Markus Schneider, Julian Gebhardt, Jan Goßmann, Mohamed Marwan, Holger Naujoks, Mara Dörken, L. Schramm, Ewelina Sobkowiak, Michael Heckel, Joanna Harazny, Arnfried Klingbeil, J Zimmermann, Maria Moritz, Heribert Fink, Raoul Zeltner, Patrick Biggar, Rolf Janka, Ahmet Cakmak, Stefan Büttner, Christoph Betz, Fabian Hammer, Heike Schneider, Sarah Rudolf, Beate Schamberger, Imke Reimer, Claudius Kleinert, Michael Brunner, Sabine Schütterle, Susanne Schwedler, Vera Krane, Thorsten Klink, Sophie Richter, Christian Ritter, Markus Schöffauer, Tilo Freiwald, Helmut Geiger, Ulrike Raff, Benjamin-Florian Koch, Renate Hammerstingl, Thomas Bochannek, Joachim Hoyer, Wolfgang Freisinger, Paul Würmell, Daniel Sollinger, Vladimir Vasiljuk, Michael Schmid, Clemens Reichert, Jens Lutz, Stefan Störk, Reinhard Schneider, Andrea Heyd-Schramm, Thomas Döltz, Brigitte Moye, Kai-Olaf Netzer, Kai-Uwe Eckardt, Jurij Ribel, Christoph Wanner, Julian Donhauser, Thorsten Walther, Julia Weinmann-Menke, Judith Kosowski |
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| Rok vydání: | 2019 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Hyperkalemia Heart Ventricles medicine.medical_treatment 030232 urology & nephrology Diastole Spironolactone Placebos 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Renal Dialysis Internal medicine Humans Medicine Ventricular remodeling Aged Mineralocorticoid Receptor Antagonists Heart Failure Ejection fraction Ventricular Remodeling business.industry Stroke Volume Middle Aged medicine.disease Magnetic Resonance Imaging Treatment Outcome 030104 developmental biology Blood pressure chemistry Nephrology Heart failure Cardiology Kidney Failure Chronic Female Hemodialysis medicine.symptom business |
| Zdroj: | Kidney International. 95:983-991 |
| ISSN: | 0085-2538 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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