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Combined Treatment of Resistant Hypertension and Atrial Fibrillation

Primary Purpose

Hypertension, Resistant to Conventional Therapy, Atrial Fibrillation

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Circumferential PV isolation

Circumferential PVI+renal denervation

About this trial

This is an interventional treatment trial for Hypertension, Resistant to Conventional Therapy focused on measuring Resistant hypertension, Atrial Fibrillation, Percutaneous renal denervation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Valley Health System
State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Circumferential PVI

Circumferential PVI+renal denervation

Arm Description

Outcomes

Primary Outcome Measures

Freedom of AF or other atrial arrhythmias

Secondary Outcome Measures

Systolic blood pressure lowering

Full Information

NCT ID

NCT01117025

First Posted

April 30, 2010

Last Updated

July 8, 2013

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT01117025

Brief Title

Combined Treatment of Resistant Hypertension and Atrial Fibrillation

Official Title

The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Resistant to Conventional Therapy, Atrial Fibrillation

Keywords

Resistant hypertension, Atrial Fibrillation, Percutaneous renal denervation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Circumferential PVI

Arm Type

Active Comparator

Arm Title

Circumferential PVI+renal denervation

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Circumferential PV isolation

Intervention Description

The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.

Intervention Type

Procedure

Intervention Name(s)

Circumferential PVI+renal denervation

Intervention Description

The procedure of AF ablation is the same like in the circumferential PV isolation. After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.

Primary Outcome Measure Information:

Title

Freedom of AF or other atrial arrhythmias

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Systolic blood pressure lowering

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evgeny A Pokushalov, MD, PhD

Organizational Affiliation

State Research Institute of Circulation Pathology

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Valley Health System

City

New York

State/Province

New York

Country

United States

Facility Name

State Research Institute of Circulation Pathology

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

22958958

Citation

Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Baranova V, Turov A, Shirokova N, Karaskov A, Mittal S, Steinberg JS. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol. 2012 Sep 25;60(13):1163-70. doi: 10.1016/j.jacc.2012.05.036. Epub 2012 Sep 5.

Results Reference

result

PubMed Identifier

24691452

Citation

Pokushalov E, Romanov A, Katritsis DG, Artyomenko S, Bayramova S, Losik D, Baranova V, Karaskov A, Steinberg JS. Renal denervation for improving outcomes of catheter ablation in patients with atrial fibrillation and hypertension: early experience. Heart Rhythm. 2014 Jul;11(7):1131-8. doi: 10.1016/j.hrthm.2014.03.055. Epub 2014 Mar 29.

Results Reference

derived

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Combined Treatment of Resistant Hypertension and Atrial Fibrillation

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