Combined Treatment of Resistant Hypertension and Atrial Fibrillation

Phase 2

Completed

• Conditions: Hypertension, Resistant to Conventional Therapy; Atrial Fibrillation
• Interventions: Procedure: Circumferential PV isolation; Procedure: Circumferential PVI+renal denervation

• Registration Number: NCT01117025
• 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 hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Primary Completion: 2011-08
• Study Completion: 2012-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-08
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Freedom of AF or other atrial arrhythmias	1 year

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure lowering	1 year

Trial Locations

Locations (2)

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

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