Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

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

P. Osmancik, Š. Havránek, V. Bulková, J. Chovančík, T. Roubíček, D. Heřman, Z. Čarná, V. Tuka, M. Matoulek, M. Fiala, O. Jiravský, S. Stregl-Hruskova, A. Latiňák, J. Kotryová, J. Jarkovský

. 2022 ; 12 (6) : e056522. [pub] 20220615

Jazyk angličtina Země Velká Británie

Typ dokumentu protokol klinické studie, časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22017995

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 >30 s. 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. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04011800).

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22017995
003      
CZ-PrNML
005      
20250617140410.0
007      
ta
008      
220720s2022 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1136/bmjopen-2021-056522 $2 doi
035    __
$a (PubMed)35705334
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Osmancik, Pavel $u Department of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech Republic pavel.osmancik@gmail.com $u Department of Cardiology, 3rd Faculty of Medicine, Charles University, Prague, Czech Republic $1 https://orcid.org/0000000304824448 $7 xx0104796
245    10
$a Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial) / $c P. Osmancik, Š. Havránek, V. Bulková, J. Chovančík, T. Roubíček, D. Heřman, Z. Čarná, V. Tuka, M. Matoulek, M. Fiala, O. Jiravský, S. Stregl-Hruskova, A. Latiňák, J. Kotryová, J. Jarkovský
520    9_
$a 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 >30 s. 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. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04011800).
650    _2
$a antiarytmika $x terapeutické užití $7 D000889
650    12
$a fibrilace síní $x farmakoterapie $x chirurgie $7 D001281
650    12
$a katetrizační ablace $x metody $7 D017115
650    _2
$a lidé $7 D006801
650    _2
$a multicentrické studie jako téma $7 D015337
650    _2
$a prospektivní studie $7 D011446
650    _2
$a kvalita života $7 D011788
650    _2
$a randomizované kontrolované studie jako téma $7 D016032
650    _2
$a recidiva $7 D012008
650    _2
$a rizikové faktory $7 D012307
650    _2
$a výsledek terapie $7 D016896
650    _2
$a hmotnostní úbytek $7 D015431
655    _2
$a protokol klinické studie $7 D000078325
655    _2
$a časopisecké články $7 D016428
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Havránek, Štěpán $u Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Prague, Czech Republic
700    1_
$a Bulková, Veronika $u Department of Cardiology, University Hospital Brno, Brno, Czech Republic
700    1_
$a Chovančík, Jan $u Department of Cardiology, Charles University, Prague, Czech Republic
700    1_
$a Roubíček, Tomáš $u Department of Cardiology, Regional Hospital Liberec, Liberec, Czech Republic
700    1_
$a Heřman, Dalibor $u Department of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech Republic $u Department of Cardiology, 3rd Faculty of Medicine, Charles University, Prague, Czech Republic
700    1_
$a Čarná, Zuzana $u Department of Cardiology, Kralovske Vinohrady University Hospital, Prague, Czech Republic $u Department of Cardiology, 3rd Faculty of Medicine, Charles University, Prague, Czech Republic $7 xx0333144
700    1_
$a Tuka, Vladimír $u Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Prague, Czech Republic
700    1_
$a Matoulek, Martin $u Cardiocenter, Second Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Prague, Czech Republic
700    1_
$a Fiala, Martin $u Department of Cardiology, University Hospital Brno, Brno, Czech Republic
700    1_
$a Jiravský, Otakar $u Department of Cardiology, Charles University, Prague, Czech Republic
700    1_
$a Stregl-Hruskova, Sylvie $u Department of Cardiology, Regional Hospital Liberec, Liberec, Czech Republic
700    1_
$a Latiňák, Adam $u Department of Cardiology, Regional Hospital Liberec, Liberec, Czech Republic
700    1_
$a Kotryová, Jiřina $u Masaryk University, Brno, Czech Republic
700    1_
$a Jarkovský, Jiří $u Institute of Biostatistics and Analyses, Brno University of Technology, Brno, Czech Republic
773    0_
$w MED00184484 $t BMJ open $x 2044-6055 $g Roč. 12, č. 6 (2022), s. e056522
856    41
$u https://pubmed.ncbi.nlm.nih.gov/35705334 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220720 $b ABA008
991    __
$a 20250617140402 $b ABA008
999    __
$a ok $b bmc $g 1821871 $s 1169238
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2022 $b 12 $c 6 $d e056522 $e 20220615 $i 2044-6055 $m BMJ open $n BMJ Open $x MED00184484
LZP    __
$a Pubmed-20220720

Najít záznam

Citační ukazatele

Možnosti archivace