Selenium supplementation in patients with peripartum cardiomyopathy: a proof-of-concept trial.
BMC Cardiovasc Disord
; 20(1): 457, 2020 10 21.
Article
en En
| MEDLINE
| ID: mdl-33087055
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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Trastornos Puerperales
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Selenio
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Selenometionina
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Suplementos Dietéticos
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Enfermedades Carenciales
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Insuficiencia Cardíaca
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Cardiomiopatías
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Adult
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Female
/
Humans
/
Pregnancy
País/Región como asunto:
Africa
Idioma:
En
Revista:
BMC Cardiovasc Disord
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2020
Tipo del documento:
Article
País de afiliación:
Nigeria