Combined Treatment of Arterial Hypertension and Atrial Fibrillation

Meshalkin Research Institute of Pathology of Circulation

Status and phase

Completed

Phase 2

Conditions

Atrial Fibrillation

Arterial Hypertension

Treatments

Procedure: Circumferential PV isolation

Procedure: PV isolation+renal denervation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01897545

RDAFA-030

Details and patient eligibility

About

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/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.

Full description

On the basis of the eligibility criteria, patients is assigned by the enrolling physician to one of two strata. The first stratum includes patients with moderate drug-resistant hypertension, defined by the Joint National Committee VII and ESH/ESC guidelines as office BP ≥ 140/90 mm Hg and <160/100 mm Hg. The second stratum includes patients with drug-resistant hypertension, defined by office BP ≥ 160/100 mm Hg.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 ≥140/90 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

Secondary causes of hypertension
Severe renal artery stenosis or dual renal arteries
Congestive heart failure with NYHA II-IV symptoms
Left ventricular ejection fraction <35%
Transverse left atrial diameter > 60 mm on transthoracic echocardiography
1. Previous AF ablation procedure
2. Treatment with amiodarone
Previous renal artery stenting or angioplasty
Type 1 diabetes mellitus