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.

Phenotyping Stroke in Sub-Saharan Africa: Stroke Investigative Research and Education Network (SIREN) Phenomics Protocol.

BACKGROUND: As the second leading cause of death and the leading cause of adult-onset disability, stroke is a major public health concern particularly pertinent in Sub-Saharan Africa (SSA), where nearly 80% of all global stroke mortalities occur, and stroke burden is projected to increase in the coming decades. However, traditional and emerging risk factors for stroke in SSA have not been well characterized, thus limiting efforts at curbing its devastating toll. The Stroke Investigative Research and Education Network (SIREN) project is aimed at comprehensively evaluating the key environmental and genomic risk factors for stroke (and its subtypes) in SSA while simultaneously building capacities in phenomics, biobanking, genomics, biostatistics, and bioinformatics for brain research. METHODS: SIREN is a transnational, multicentre, hospital and community-based study involving 3,000 cases and 3,000 controls recruited from 8 sites in Ghana and Nigeria. Cases will be hospital-based patients with first stroke within 10 days of onset in whom neurovascular imaging will be performed. Etiological and topographical stroke subtypes will be documented for all cases. Controls will be hospital- and community-based participants, matched to cases on the basis of gender, ethnicity, and age (±5 years). Information will be collected on known and proposed emerging risk factors for stroke. STUDY SIGNIFICANCE: SIREN is the largest study of stroke in Africa to date. It is anticipated that it will shed light on the phenotypic characteristics and risk factors of stroke and ultimately provide evidence base for strategic interventions to curtail the burgeoning burden of stroke on the sub-continent.

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

AIMS: The prospective, multicentre Peripartum Cardiomyopathy in Nigeria (PEACE) registry originally demonstrated a high prevalence of peripartum cardiomyopathy (PPCM) among patients originating from Kano, North-West Nigeria. In a post hoc analysis, we sought to determine if this phenomenon was characterized by a differential case profile and outcome among PPCM cases originating elsewhere. METHODS AND RESULTS: Overall, 199 (81.6%) of a total 244 PPCM patients were recruited from three sites in Kano, compared with 45 patients (18.4%) from 11 widely dispersed centres across Nigeria. Presence and extent of ventricular myocardial remodelling during follow-up, relative to baseline status, were assessed by echocardiography. During median 17 months follow-up, Kano patients demonstrated significantly better myocardial reverse remodelling than patients from other sites. Overall, 50.6% of patients from Kano versus 28.6% from other regions were asymptomatic (P = 0.029) at study completion, with an accompanying difference in all-cause mortality (17.6% vs. 22.2% respectively, P = 0.523) not reaching statistical significance. Alternatively, 135/191 (84.9%) of Kano patients had selenium deficiency (<70 µg/L), and 46/135 (34.1%) of them received oral selenium supplementation. Critically, those that received selenium supplementation demonstrated better survival (6.5% vs. 21.2%; P = 0.025), but the supplement did not have significant impact on myocardial remodelling. CONCLUSIONS: This study has shown important non-racial regional disparities in the clinical features and outcomes of PPCM patients in Nigeria, that might partly be explained by selenium supplementation.

Clinical Features and Outcomes of Peripartum Cardiomyopathy in Nigeria.

BACKGROUND: Nigeria has the highest incidence of peripartum cardiomyopathy (PPCM) in the world. However, data on PPCM-related outcomes are limited. OBJECTIVES: The purpose of this study was to examine the clinical profile, myocardial remodeling, and survival of patients with PPCM in Nigeria. METHODS: This study consecutively recruited 244 PPCM patients (median 7 months postpartum) at 14 sites in Nigeria and applied structured follow-up for a median of 17 months (interquartile range: 14 to 20 months). Left ventricular reverse remodeling (LVRR) was defined as the composite of left ventricular (LV) end-diastolic dimension <33 mm/m2 and absolute increase in left ventricular ejection fraction (LVEF) ≥10%. LV full recovery was defined as LVEF ≥55%. RESULTS: Overall, 45 (18.7%) patients died during follow-up. Maternal age <20 years (hazard ratio [HR]: 2.40; 95% confidence interval (CI): 1.27 to 4.54), hypotension (HR: 1.87; 95% CI: 1.02 to 3.43), tachycardia (HR: 2.38; 95% CI: 1.05 to 5.43), and LVEF <25% at baseline (HR: 2.11; 95% CI: 1.12 to 3.95) independently predicted mortality. Obesity (HR: 0.16; 95% CI: 0.04 to 0.55) and regular use of beta-blockers at 6-month follow-up (HR: 0.20; 95% CI: 0.09 to 0.41) were independently associated with reduced risk for mortality. In total, 48 patients (24.1%) achieved LVRR and 45 (22.6%) achieved LV full recovery. LVEF <25% at baseline (HR: 0.66; 95% CI: 0.47 to 0.92) and regular use of beta-blockers at 6-month follow-up (HR: 1.62; 95% CI: 1.17 to 2.25) independently determined the risk for LV full recovery. Progressive reverse remodeling of all cardiac chambers was observed. In total, 18 patients (7.4%) were hospitalized during the study. CONCLUSIONS: This is the largest study of PPCM in Africa. Consistent with late presentations, the mortality rate was high, whereas frequencies of LVRR and LV full recovery were low. Several variables predicted poor outcomes, and regular use of beta-blockers correlated with late survival and LV functional recovery.