1. Selenium supplementation in patients with peripartum cardiomyopathy: a proof-of-concept trial.
- Author
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Karaye KM, Sa'idu H, Balarabe SA, Ishaq NA, Sanni B, Abubakar H, Mohammed BL, Abdulsalam T, Tukur J, and Mohammed IY
- Subjects
- Adult, Cardiomyopathies diagnosis, Cardiomyopathies mortality, Cardiomyopathies physiopathology, Deficiency Diseases diagnosis, Deficiency Diseases mortality, Deficiency Diseases physiopathology, Female, Heart Failure diagnosis, Heart Failure mortality, Heart Failure physiopathology, Humans, Nigeria, Peripartum Period, Pregnancy, Proof of Concept Study, Prospective Studies, Puerperal Disorders diagnosis, Puerperal Disorders mortality, Puerperal Disorders physiopathology, Selenomethionine adverse effects, Stroke Volume drug effects, Time Factors, Treatment Outcome, Ventricular Function, Left drug effects, Young Adult, Cardiomyopathies drug therapy, Deficiency Diseases drug therapy, Dietary Supplements adverse effects, Heart Failure drug therapy, Puerperal Disorders drug therapy, Selenium deficiency, Selenomethionine therapeutic use
- Abstract
Background: We studied the efficacy and safety of selenium supplementation in patients who had peripartum cardiomyopathy (PPCM) and selenium deficiency., Methods: We randomly assigned 100 PPCM patients with left ventricular ejection fraction (LVEF) < 45% and selenium deficiency (< 70 μg/L) to receive either oral Selenium (L-selenomethionine) 200 μg/day for 3 months or nothing, in addition to recommended therapy, in an open-label randomised trial. The primary outcome was a composite of persistence of heart failure (HF) symptoms, unrecovered LV systolic function (LVEF < 55%) or death from any cause., Results: Over a median of 19 months, the primary outcome occurred in 36 of 46 patients (78.3%) in the selenium group and in 43 of 54 patients (79.6%) in the control group (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.43-1.09; p = 0.113). Persistence of HF symptoms occurred in 18 patients (39.1%) in the selenium group and in 37 patients (68.5%) in the control group (HR 0.53; 95% CI 0.30-0.93; p = 0.006). LVEF < 55% occurred in 33 patients (71.7%) in the selenium group and in 38 patients (70.4%) in the control group (HR 0.91; 95% CI 0.57-1.45; p = 0.944). Death from any cause occurred in 3 patients (6.5%) in the selenium group and in 9 patients (16.7%) in the control group (HR 0.37; 95% CI 0.10-1.37; p = 0.137)., Conclusions: In this study, selenium supplementation did not reduce the risk of the primary outcome, but it significantly reduced HF symptoms, and there was a trend towards a reduction of all-cause mortality., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03081949.
- Published
- 2020
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