Catheter ablation versus antiarrhythmic drugs with risk factor
modification for treatment of atrial fibrillation: a protocol
of a randomised controlled trial (PRAGUE-25 trial)

J 2022

Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)

OSMANCIK, Pavel, Štěpán HAVRÁNEK, Veronika BULKOVÁ, Jan CHOVANČÍK, Tomáš ROUBÍČEK et. al.

Základní údaje

Originální název

Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)

Autoři

OSMANCIK, Pavel (203 Česká republika, garant), Štěpán HAVRÁNEK (203 Česká republika), Veronika BULKOVÁ (203 Česká republika), Jan CHOVANČÍK (203 Česká republika), Tomáš ROUBÍČEK (203 Česká republika), Dalibor HEŘMAN (203 Česká republika), Zuzana ČARNÁ (203 Česká republika), Vladimír TUKA, Martin MATOULEK (203 Česká republika), Martin FIALA (203 Česká republika), Otakar JIRAVSKÝ (203 Česká republika), Sylvie STREGL-HRUSKOVA (203 Česká republika), Adam LATIŇÁK (203 Česká republika), Jiřina KOTRYOVÁ (203 Česká republika, domácí) a Jiří JARKOVSKÝ (203 Česká republika)

Vydání

BMJ Open, London, BMJ Publishing Group, 2022, 2044-6055

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30218 General and internal medicine

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.900

Kód RIV

RIV/00216224:14110/22:00126140

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1136/bmjopen-2021-056522

UT WoS

000812378000015

Klíčová slova anglicky

Catheter ablation; antiarrhythmic drugs; atrial fibrillation

Štítky

14119612, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 14. 3. 2023 08:17, Mgr. Tereza Miškechová

Anotace

V originále

Introduction Atrial fibrillation (AF), with a prevalence of 2%, is the most common cardiac arrhythmia. Catheter ablation (CA) has been documented to be superior to treatment by antiarrhythmic drugs (AADs) in terms of sinus rhythm maintenance. However, in obese patients, substantial weight loss was also associated with AF reduction. So far, no study has compared the modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA) treatment. The aim of the trial is to compare the efficacy of modern invasive (CA) and non-invasive (AADs with risk factor management) treatment of AF. Methods and analysis The trial will be a prospective, multicentre, randomised non-inferiority trial. Patients with symptomatic AF and a body mass index >30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio. In the CA arm, pulmonary vein isolation (in combination with additional lesion sets in non-paroxysmal patients) will be performed. For patients in the RFM+AAD arm, the aim will be a 10% weight loss over 6-12 months, increased physical fitness and a reduction in alcohol consumption. The primary endpoint will be an episode of AF or regular atrial tachycardia lasting >30s. The secondary endpoints include AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints. An AF freedom of 65% in the RFM+AAD and of 60% in the CA is expected; therefore, 202 patients will be enrolled to achieve the non-inferiority with 80% power, 5% one-sided alpha and a non-inferiority margin of 12%. Ethics and dissemination The PRAGUE-25 trial will determine if modern non-invasive AF treatment strategies are non-inferior to CA. The study was approved by the Ethics Committee of the University Hospital Kralovske Vinohrady. Results of the study will be disseminated on scientific conferences and in peer-reviewed scientific journals. After the end of follow-up, data will be available upon request to principal investigator.

Citovat

OSMANCIK, Pavel, Štěpán HAVRÁNEK, Veronika BULKOVÁ, Jan CHOVANČÍK, Tomáš ROUBÍČEK, Dalibor HEŘMAN, Zuzana ČARNÁ, Vladimír TUKA, Martin MATOULEK, Martin FIALA, Otakar JIRAVSKÝ, Sylvie STREGL-HRUSKOVA, Adam LATIŇÁK, Jiřina KOTRYOVÁ a Jiří JARKOVSKÝ. Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial). BMJ Open. London: BMJ Publishing Group, 2022, roč. 12, č. 6, s. 1-8. ISSN 2044-6055. Dostupné z: https://dx.doi.org/10.1136/bmjopen-2021-056522.

@article{1863060,
   author = {Osmancik, Pavel and Havránek, Štěpán and Bulková, Veronika and Chovančík, Jan and Roubíček, Tomáš and Heřman, Dalibor and Čarná, Zuzana and Tuka, Vladimír and Matoulek, Martin and Fiala, Martin and Jiravský, Otakar and StreglandHruskova, Sylvie and Latiňák, Adam and Kotryová, Jiřina and Jarkovský, Jiří},
   article_location = {London},
   article_number = {6},
   doi = {http://dx.doi.org/10.1136/bmjopen-2021-056522},
   keywords = {Catheter ablation; antiarrhythmic drugs; atrial fibrillation},
   language = {eng},
   issn = {2044-6055},
   journal = {BMJ Open},
   title = {Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)},
   url = {https://bmjopen.bmj.com/content/12/6/e056522},
   volume = {12},
   year = {2022}
}

TY  - JOUR
ID  - 1863060
AU  - Osmancik, Pavel - Havránek, Štěpán - Bulková, Veronika - Chovančík, Jan - Roubíček, Tomáš - Heřman, Dalibor - Čarná, Zuzana - Tuka, Vladimír - Matoulek, Martin - Fiala, Martin - Jiravský, Otakar - Stregl-Hruskova, Sylvie - Latiňák, Adam - Kotryová, Jiřina - Jarkovský, Jiří
PY  - 2022
TI  - Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial)
JF  - BMJ Open
VL  - 12
IS  - 6
SP  - 1-8
EP  - 1-8
PB  - BMJ Publishing Group
SN  - 20446055
KW  - Catheter ablation
KW  - antiarrhythmic drugs
KW  - atrial fibrillation
UR  - https://bmjopen.bmj.com/content/12/6/e056522
N2  - Introduction Atrial fibrillation (AF), with a prevalence of 2%, is the most common cardiac arrhythmia. Catheter ablation (CA) has been documented to be superior to treatment by antiarrhythmic drugs (AADs) in terms of sinus rhythm maintenance. However, in obese patients, substantial weight loss was also associated with AF reduction. So far, no study has compared the modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA) treatment. The aim of the trial is to compare the efficacy of modern invasive (CA) and non-invasive (AADs with risk factor management) treatment of AF. Methods and analysis The trial will be a prospective, multicentre, randomised non-inferiority trial. Patients with symptomatic AF and a body mass index >30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio. In the CA arm, pulmonary vein isolation (in combination with additional lesion sets in non-paroxysmal patients) will be performed. For patients in the RFM+AAD arm, the aim will be a 10% weight loss over 6-12 months, increased physical fitness and a reduction in alcohol consumption. The primary endpoint will be an episode of AF or regular atrial tachycardia lasting >30s. The secondary endpoints include AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints. An AF freedom of 65% in the RFM+AAD and of 60% in the CA is expected; therefore, 202 patients will be enrolled to achieve the non-inferiority with 80% power, 5% one-sided alpha and a non-inferiority margin of 12%. Ethics and dissemination The PRAGUE-25 trial will determine if modern non-invasive AF treatment strategies are non-inferior to CA. The study was approved by the Ethics Committee of the University Hospital Kralovske Vinohrady. Results of the study will be disseminated on scientific conferences and in peer-reviewed scientific journals. After the end of follow-up, data will be available upon request to principal investigator.
ER  -

OSMANCIK, Pavel, Štěpán HAVRÁNEK, Veronika BULKOVÁ, Jan CHOVANČÍK, Tomáš ROUBÍČEK, Dalibor HEŘMAN, Zuzana ČARNÁ, Vladimír TUKA, Martin MATOULEK, Martin FIALA, Otakar JIRAVSKÝ, Sylvie STREGL-HRUSKOVA, Adam LATIŇÁK, Jiřina KOTRYOVÁ a Jiří JARKOVSKÝ. Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial). \textit{BMJ Open}. London: BMJ Publishing Group, 2022, roč.~12, č.~6, s.~1-8. ISSN~2044-6055. Dostupné z: https://dx.doi.org/10.1136/bmjopen-2021-056522.

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