Combined Treatment of Resistant Hypertension and Atrial Fibrillation

Completed · Phase 2

Conditions studied: Hypertension, Resistant to Conventional Therapy, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01117025

Run by

Meshalkin Research Institute of Pathology of Circulation

People needed

26

Starts

2010-04-01

Expected to finish

2012-04-01

Last updated by the study team

2013-07-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Valley Health System — New York, New York, United States
• State Research Institute of Circulation Pathology — Novosibirsk, Russia

Full record on ClinicalTrials.gov

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