Combined Treatment of Arterial Hypertension and Atrial Fibrillation

Phase 2

Completed

• Conditions: Atrial Fibrillation; Arterial Hypertension
• Interventions: Procedure: Circumferential PV isolation; Procedure: PV isolation+renal denervation

• Registration Number: NCT01897545
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PV isolation	Circumferential PV isolation	-
PV isolation+renal denervation	PV isolation+renal denervation	-

Primary Outcome Measures

Name	Time	Method
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug	1 year

Secondary Outcome Measures

Name	Time	Method
office blood pressure	1 year
safety data before and at 3, 6, 9, and 12 months after procedure	1 year

Trial Locations

Locations (3)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation

Athens Euroclinic; 🇬🇷 Athens, Greece

The Valley Health System; 🇺🇸 New York, New York, United States