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

• Published in: Clinical research in cardiology 2018-07, Vol.107 (7), p.539-547
• Main Authors: de Jong, Mark R, Hoogerwaard, Annemiek F, Adiyaman, Ahmet, Smit, Jaap Jan J, Anand R Ramdat Misier, Jan-Evert Heeg, Boudewijn A A M van Hasselt, Van Gelder, Isabelle C, Harry J G M Crijns, Ignacio Fernández Lozano, Toquero Ramos, Jorge E, Alzueta, F Javier, Ibañez, Borja, Rubio, José M, Arribas, Fernando, Porres Aracama, José M, Brugada, Josep, Mont, Lluís, Arif Elvan
• Format: Article
• Language: English
• Subjects: Antihypertensives; Blanking; Blood pressure; Cardiac arrhythmia; Denervation; Design modifications; Diabetes mellitus; Fever; Fibrillation; Hypertension; Patients; Randomization; Renal artery; Risk factors; Sympathetic nervous system; Tachycardia; Veins & arteries
• ISSN: 1861-0684; 1861-0692
• DOI: 10.1007/s00392-018-1214-6

BackgroundHypertension 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.ObjectiveThe goal of this multicenter randomized controlled study is to investigate whether RDN added to PVI reduces AF recurrence.MethodsThe 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.ResultsPatients will have follow-up for 1 year, and continuous loop monitoring is advocated.ConclusionThis randomized, controlled study will elucidate if RDN on top of PVI reduces AF recurrence.