Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F25%3A00010191" target="_blank" >RIV/00023884:_____/25:00010191 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/25:10511080

Výsledek na webu

<a href="https://onlinelibrary-wiley-com.ezproxy.lib.cas.cz/doi/full/10.1002/ejhf.3763" target="_blank" >https://onlinelibrary-wiley-com.ezproxy.lib.cas.cz/doi/full/10.1002/ejhf.3763</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/ejhf.3763" target="_blank" >10.1002/ejhf.3763</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial

Popis výsledku v původním jazyce

Aims In patients with heart failure, alterations in electrical fields generated within the myocardium have been associated with myocardial oedema which can act as a substrate for left ventricular dysfunction. Safety and efficacy of a direct microcurrent therapy using an implanted generator (C-MIC) remain uncertain. Methods and results Ambulatory patients with non-ischaemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 25% to 35% and New York Heart Association (NYHA) class III-IV were randomized to C-MIC (device) or control group in addition to guideline-directed medical therapy. The primary endpoint was change in LVEF at 6 months. Pre-specified secondary endpoints included 6-min walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS), and NYHA functional class. Of 70 patients randomized, 65 were included in modified intention-to-treat analysis (C-MIC device: n = 32; control: n = 33). At 6 months, treatment with C-MIC versus control improved LVEF (mean difference: 5.1%; 95% confidence interval [CI] 3.1-7.1%, p < 0.001). The proportions of patients with improvement in at least one NYHA class (risk difference: 68.9%; 95% CI 50.6-87.2, p < 0.001), an increase of >= 5 points in KCCQ-OSS (risk difference: 60.0%; 95% CI 42.3-77.6, p < 0.001), and an increase of >= 30% in 6MWD (risk difference: 38.3%; 95% CI 14.4-62.2) were substantially higher in the device versus control group (p < 0.002). Conclusions In patients with non-ischaemic chronic heart failure with reduced ejection fraction, the C-MIC device compared with control improved LVEF, symptoms, functional capacity and quality of life.

Název v anglickém jazyce

Cardio-microcurrent device treatment for heart failure with reduced ejection fraction: Results from the C-MIC II open-label randomized controlled trial

Popis výsledku anglicky

Aims In patients with heart failure, alterations in electrical fields generated within the myocardium have been associated with myocardial oedema which can act as a substrate for left ventricular dysfunction. Safety and efficacy of a direct microcurrent therapy using an implanted generator (C-MIC) remain uncertain. Methods and results Ambulatory patients with non-ischaemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 25% to 35% and New York Heart Association (NYHA) class III-IV were randomized to C-MIC (device) or control group in addition to guideline-directed medical therapy. The primary endpoint was change in LVEF at 6 months. Pre-specified secondary endpoints included 6-min walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS), and NYHA functional class. Of 70 patients randomized, 65 were included in modified intention-to-treat analysis (C-MIC device: n = 32; control: n = 33). At 6 months, treatment with C-MIC versus control improved LVEF (mean difference: 5.1%; 95% confidence interval [CI] 3.1-7.1%, p < 0.001). The proportions of patients with improvement in at least one NYHA class (risk difference: 68.9%; 95% CI 50.6-87.2, p < 0.001), an increase of >= 5 points in KCCQ-OSS (risk difference: 60.0%; 95% CI 42.3-77.6, p < 0.001), and an increase of >= 30% in 6MWD (risk difference: 38.3%; 95% CI 14.4-62.2) were substantially higher in the device versus control group (p < 0.002). Conclusions In patients with non-ischaemic chronic heart failure with reduced ejection fraction, the C-MIC device compared with control improved LVEF, symptoms, functional capacity and quality of life.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

European Journal of Heart Failure

ISSN

1388-9842

e-ISSN

—

Svazek periodika

27

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

13

Strana od-do

1837-1849

Kód UT WoS článku

001529008900001

EID výsledku v databázi Scopus

2-s2.0-105012486940