ClinicalTrials.Veeva

Menu

Combined Treatment of Resistant Hypertension and Atrial Fibrillation

M

Meshalkin Research Institute of Pathology of Circulation

Status and phase

Completed
Phase 2

Conditions

Atrial Fibrillation
Hypertension, Resistant to Conventional Therapy

Treatments

Procedure: Circumferential PV isolation
Procedure: Circumferential PVI+renal denervation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01117025
RU MC 001 (Other Identifier)
RDAFA-029

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 hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.

Enrollment

26 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 ≥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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 2 patient groups

Circumferential PVI
Active Comparator group
Treatment:
Procedure: Circumferential PV isolation
Circumferential PVI+renal denervation
Active Comparator group
Treatment:
Procedure: Circumferential PVI+renal denervation

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems