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

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.

Registry for Acute Coronary Events in Nigeria (RACE-Nigeria): Clinical Characterization, Management, and Outcome.

Background Coronary artery disease was hitherto a rarity in Africa. Acute coronary syndrome (ACS) accounts for coronary artery disease-related morbidity and mortality. Reports on ACS in Africa are few. Methods and Results We enrolled 1072 indigenous Nigerian people 59.2±12.4 years old (men, 66.8%) with ACS in an observational multicentered national registry (2013-2018). Outcome measures included incidence, intervention times, reperfusion rates, and 1-year mortality. The incidence of ACS was 59.1 people per 100 000 hospitalized adults per year, and comprised ST-segment-elevation myocardial infarction (48.7%), non-ST-segment-elevation myocardial infarction (24.5%), and unstable angina (26.8%). ACS frequency peaked 10 years earlier in men than women. Patients were predominantly from urban settings (87.3%). Median time from onset of symptoms to first medical contact (patients with ST-segment-elevation myocardial infarction) was 6 hours (interquartile range, 20.1 hours), and only 11.9% presented within a 12-hour time window. Traditional risk factors of coronary artery disease were observed. The coronary angiography rate was 42.4%. Reperfusion therapies included thrombolysis (17.1%), percutaneous coronary intervention (28.6%), and coronary artery bypass graft (11.2%). Guideline-based pharmacotherapy was adequate. Major adverse cardiac events were 30.8%, and in-hospital mortality was 8.1%. Mortality rates at 30 days, 3 months, 6 months, and 1 year were 8.7%, 9.9%, 10.9%, and 13.3%, respectively. Predictors of mortality included resuscitated cardiac arrest (odds ratio [OR], 50.0; 95% CI, 0.010-0.081), nonreperfusion (OR, 34.5; 95% CI, 0.004-0.221), pulmonary edema (OR, 11.1; 95% CI, 0.020-0.363), left ventricular diastolic dysfunction (OR, 4.1; 95% CI, 0.091-0.570), and left ventricular systolic dysfunction (OR, 2.1; 95% CI, 1.302-3.367). Conclusions ACS burden is rising in Nigeria, and patients are relatively young and from an urban setting. The system of care is evolving and is characterized by lack of capacity and low patient eligibility for reperfusion. We recommend preventive strategies and health care infrastructure-appropriate management guidelines.