TY - JOUR
T1 - Treatment of atrial fibrillation in patients with enhanced sympathetic tone by pulmonary vein isolation or pulmonary vein isolation and renal artery denervation: clinical background and study design
AU - de Jong, Mark R.
AU - Hoogerwaard, Annemiek F.
AU - Adiyaman, Ahmet
AU - Smit, Jaap Jan J.
AU - Misier, Anand R. Ramdat
AU - Heeg, Jan-Evert
AU - van Hasselt, Boudewijn A. A. M.
AU - Van Gelder, Isabelle C.
AU - Crijns, Harry J. G. M.
AU - Lozano, Ignacio
AU - Ramos, Jorge E.
AU - Alzueta, F.
AU - Ibanez, Borja
AU - Rubio, Jose M.
AU - Arribas, Fernando
AU - Aracama, Jose M.
AU - Brugada, Josep
AU - Mont, Lluis
AU - Elvan, Arif
PY - 2018/7/1
Y1 - 2018/7/1
N2 - Background Hypertension is an important, modifiable risk factor for the development of atrial fibrillation (AF). Even after pulmonary vein isolation (PVI), 20-40% experience recurrent AF. Animal studies have shown that renal denervation (RDN) reduces AF inducibility. One clinical study with important limitations suggested that RDN additional to PVI could reduce recurrent AF. Objective The goal of this multicenter randomized controlled study is to investigate whether RDN added to PVI reduces AF recurrence. Methods The main end point is the time until first AF recurrence according to EHRA guidelines after a blanking period of 3 months. Assuming a 12-month accrual period and 12 months of follow-up, a power of 0.80, a two-sided alpha of 0.05 and an expected drop-out of 10% per group, 69 patients per group are required. We plan to randomize a total of 138 hypertensive patients with AF and signs of sympathetic overdrive in a 1:1 fashion. Patients should use at least two antihypertensive drugs. Sympathetic overdrive includes obesity, exercise-induced excessive blood pressure (BP) increase, significant white coat hypertension, hospital admission or fever induced AF, tachycardia induced AF and diabetes mellitus. The interventional group will undergo PVI + RDN and the control group will undergo PVI. Results Patients will have follow-up for 1 year, and continuous loop monitoring is advocated. Conclusion This randomized, controlled study will elucidate if RDN on top of PVI reduces AF recurrence.
AB - Background Hypertension is an important, modifiable risk factor for the development of atrial fibrillation (AF). Even after pulmonary vein isolation (PVI), 20-40% experience recurrent AF. Animal studies have shown that renal denervation (RDN) reduces AF inducibility. One clinical study with important limitations suggested that RDN additional to PVI could reduce recurrent AF. Objective The goal of this multicenter randomized controlled study is to investigate whether RDN added to PVI reduces AF recurrence. Methods The main end point is the time until first AF recurrence according to EHRA guidelines after a blanking period of 3 months. Assuming a 12-month accrual period and 12 months of follow-up, a power of 0.80, a two-sided alpha of 0.05 and an expected drop-out of 10% per group, 69 patients per group are required. We plan to randomize a total of 138 hypertensive patients with AF and signs of sympathetic overdrive in a 1:1 fashion. Patients should use at least two antihypertensive drugs. Sympathetic overdrive includes obesity, exercise-induced excessive blood pressure (BP) increase, significant white coat hypertension, hospital admission or fever induced AF, tachycardia induced AF and diabetes mellitus. The interventional group will undergo PVI + RDN and the control group will undergo PVI. Results Patients will have follow-up for 1 year, and continuous loop monitoring is advocated. Conclusion This randomized, controlled study will elucidate if RDN on top of PVI reduces AF recurrence.
KW - RDN
KW - PVI
KW - AF
KW - Hypertension
KW - Sympathetic overdrive
KW - DRUG-RESISTANT HYPERTENSION
KW - RANDOMIZED CONTROLLED-TRIAL
KW - BLOOD-PRESSURE RESPONSE
KW - NERVE-STIMULATION
KW - UNCONTROLLED HYPERTENSION
KW - CATHETER
KW - THERAPY
KW - MODEL
KW - HEMODYNAMICS
KW - MANAGEMENT
U2 - 10.1007/s00392-018-1214-6
DO - 10.1007/s00392-018-1214-6
M3 - Article
C2 - 29487995
SN - 1861-0684
VL - 107
SP - 539
EP - 547
JO - Clinical research in cardiology
JF - Clinical research in cardiology
IS - 7
ER -