Arterial HypertensionPhase 2NCT01897545
Combined Treatment of Arterial Hypertension and Atrial Fibrillation
A Phase 2 study testing Circumferential PV isolation and PV isolation+renal denervation in people with Arterial Hypertension and Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 3 sites in 3 countries.
Trial 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/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arterial Hypertension, Atrial Fibrillation
- What is being tested?
- Circumferential PV isolation and PV isolation+renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Treatment with amiodarone
- Previous renal artery stenting or angioplasty
- Type 1 diabetes mellitus
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Russia1 site
State Research Institute of Circulation Pathology
Novosibirsk, 630055
About this study
Official title: The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Atrial Fibrillation and Arterial Hypertension
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/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.
Read the 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 by the Joint National Committee VII and ESH/ESC guidelines as office BP ≥ 140/90 mm Hg and <160/100 mm Hg. The second stratum includes patients with drug-resistant hypertension, defined by office BP ≥ 160/100 mm Hg.
- Conditions
- Arterial Hypertension, Atrial Fibrillation
- Being tested
- Circumferential PV isolation, PV isolation+renal denervation
- Keywords
- Arterial hypertension, Atrial Fibrillation, Percutaneous renal denervation
- Medical subject headings
- Hypertension, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential PV isolationProcedure or surgery
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.
PV isolation+renal denervationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PV isolation | Active comparator | Not described Receives: Procedure: Circumferential PV isolation |
| PV isolation+renal denervation | Active comparator | Not described Receives: Procedure: PV isolation+renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug
Measured: 1 year
Secondary outcomes (2)
office blood pressure
Measured: 1 year
safety data before and at 3, 6, 9, and 12 months after procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897545
- Sponsor's protocol ID
- RDAFA-030
- Status last verified
- Oct 2013
- First submitted
- 3 Jul 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24691452
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Atrial Fibrillation and Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01897545
- Acronym / sponsor ID
- RDAFA-030
- Conditions
- Arterial Hypertension, Atrial Fibrillation
- Keywords
- Arterial hypertension, Atrial Fibrillation, Percutaneous renal denervation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.
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 by the Joint National Committee VII and ESH/ESC guidelines as office BP ≥ 140/90 mm Hg and <160/100 mm Hg. The second stratum includes patients with drug-resistant hypertension, defined by office BP ≥ 160/100 mm Hg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PV isolation | Active comparator | Procedure: Circumferential PV isolation |
| PV isolation+renal denervation | Active comparator | Procedure: PV isolation+renal denervation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circumferential PV isolationThe 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. | Procedure or surgery | PV isolation |
| PV isolation+renal denervationThe 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. | Procedure or surgery | PV isolation+renal denervation |
Primary outcome
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug
Time frame: 1 year
2 secondary outcomes
office blood pressure
Time frame: 1 year
safety data before and at 3, 6, 9, and 12 months after procedure
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
- Derived from this study: PubMed 24691452Pokushalov 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.
Related trials for Arterial Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Circumferential PV isolation and PV isolation+renal denervation in people with Arterial Hypertension and Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Greece, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01897545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.