Status:
COMPLETED
Combined Treatment of Arterial Hypertension and Atrial Fibrillation
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Arterial Hypertension
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 r...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
- Previous AF ablation procedure
- Treatment with amiodarone
- Previous renal artery stenting or angioplasty
- Type 1 diabetes mellitus
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01897545
Start Date
April 1 2012
End Date
June 1 2013
Last Update
October 9 2013
Active Locations (3)
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1
The Valley Health System
New York, New York, United States
2
Athens Euroclinic
Athens, Greece, 11528
3
State Research Institute of Circulation Pathology
Novosibirsk, Russia, 630055