Selenium Supplementation in Patients With Peripartum Cardiomyopathy: A Proof-of-Concept Trial

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.

Selenium supplementation in patients with peripartum cardiomyopathy: a proof-of-concept trial

“…Beta-blockers, ACEI, ARB and other recommended HF therapies have been shown to reduce mortality and morbidity in symptomatic patients with HF and reduced ejection fraction, and are strongly recommended for treatment of PPCM patients except when contraindicated [ 19 ]. Bromocriptine could be beneficial to some PPCM patients in the acute phase of the disease and may be considered [ 20 ]. Implantable cardioverter defibrillator as well as cardiac resynchronisation therapy are recommended for PPCM patients presenting with severe LV dysfunction for more than six months despite optimal medical therapy [ 19 ].…”

“…We acknowledge that the preliminary results of this study were presented at the 2020 Congress of American College of Cardiology [ 20 ].…”

Disparities in clinical features and outcomes of peripartum cardiomyopathy in high versus low prevalent regions in Nigeria

“…A key environmental factor in PPCM could be selenium deficiency, which was recently found in up to 85% of PPCM patients in Kano, and associated with 3.3‐fold lower prevalence of mortality. In the first‐ever Selenium Supplementation Trial in PPCM however, we showed that a 3 month course of selenium supplementation significantly reduced HF symptoms, with a positive trend towards survival benefit but without significant impact on myocardial reverse remodelling 14 . In contrast, selenium deficiency was found in only 22% of apparently healthy puerperal women in Kano 22 .…”

“…In the first-ever Selenium Supplementation Trial in PPCM however, we showed that a 3 month course of selenium supplementation significantly reduced HF symptoms, with a positive trend towards survival benefit but without significant impact on myocardial reverse remodelling. 14 In contrast, selenium deficiency was found in only 22% of apparently healthy puerperal women in Kano. 22 Another possibility is a genetic factor with racial significance such as the TT genotype of guanine nucleotide-binding proteins β-3 subunit.…”

“…13 Prevalence of peripartum cardiomyopathy patients in Kano with LVEF <45% at 6 months postpartum were also screened for selenium deficiency (<70 μg/L) and included in the Regional disparities in peripartum cardiomyopathy in NIgeria 3259 Selenium Supplementation Trial, which is a sub-study of the PEACE registry. 14 Patients randomized to the treatment arm in the trial received oral selenium supplementation at a dose of 200 μg/day for 3 months and were included in this post hoc analysis. 14 The other study sites in PEACE registry did not participate in the selenium trial.…”