Clinical trial NCT01117025: Combined Treatment of Resistant Hypertension and Atrial Fibrillation
Official title: The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Resistant to Conventional Therapy
Atrial Fibrillation
Keywords: Resistant hypertension
Atrial Fibrillation
Percutaneous renal denervation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2010-05-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.


Eligibility criteria: Inclusion Criteria:

* Symptomatic drug-refractory AF (with history of failure of ≥2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
* PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
* Office-based systolic blood pressure of ≥160 mm Hg, despite treatment with ≥3 antihypertensive drugs (including 1 diuretic)
* A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

* Previous atrial fibrillation ablation
* Type 1 of diabetes mellitus
* Structural heart disease
* Secondary cause of atrial hypertension
* Severe renal artery stenosis or renal arteries abnormalities
* Previous operations on renal arteries
* Pregnancy
* Previous heart, kidney, liver, or lung transplantation
* Unwillingness of participant

Primary outcomes:
measure: Freedom of AF or other atrial arrhythmias
timeFrame: 1 year
Secondary outcomes:
measure: Systolic blood pressure lowering
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: The Valley Health System
state: New York
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny A Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Baranova V, Turov A, Shirokova N, Karaskov A, Mittal S, Steinberg JS. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol. 2012 Sep 25;60(13):1163-70. doi: 10.1016/j.jacc.2012.05.036. Epub 2012 Sep 5.
citation: Pokushalov E, Romanov A, Katritsis DG, Artyomenko S, Bayramova S, Losik D, Baranova V, Karaskov A, Steinberg JS. Renal denervation for improving outcomes of catheter ablation in patients with atrial fibrillation and hypertension: early experience. Heart Rhythm. 2014 Jul;11(7):1131-8. doi: 10.1016/j.hrthm.2014.03.055. Epub 2014 Mar 29.