Arterial HypertensionERDAFNCT04055285
Effect of Renal Denervation on Atrial Fibrillation
A study testing Sympathetic Renal Denervation and Implantable Loop Recorder in people with Arterial Hypertension and Atrial Fibrillation, run by Hippocration General Hospital.
Trial summary
The purpose of the ERDAF study (Effect of Renal Denervation on Atrial Fibrillation) is to evaluate the renal sympathetic denervation in patients with resistant arterial hypertension and symptomatic paroxysmal or persistent atrial fibrillation(AF) in order to show if there is a reduction in the AF-related symptoms, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension, Atrial Fibrillation
- What is being tested?
- Sympathetic Renal Denervation and Implantable Loop Recorder
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years with resistant hypertension [Systolic Blood Pressure (SBP) ≥ 140 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 90 mmHg despite treatment with ≥ 3 antihypertensive drugs of various classes, including a diuretic) and symptomatic paroxysmal or persistent AF will be included in the study after sinus rhythm restoration
Who cannot join
- Patients with permanent AF or patients with long-standing persistent AF as defined by the current ESC guidelines for the management of AF1.
- Patients with a glomerular filtration rate (eGFR)] <45 ml / min / 1.73 m2 calculated using the CKD-EPI43.
- Patients with secondary arterial hypertension.
- Patients with an established diagnosis of resistant hypertension <6 months.
- Patients with severe renal artery stenosis or previous renal artery angioplasty.
- Patients who have undergone or are about to undergo pulmonary vein isolation.
Show all 14Show fewer
- Patients with left end-diastolic ventricle diameter >60 mm in men or >55mm in women.
- Patients with a left ventricular ejection fraction <35% in the transthoracic echocardiogram (TTE).
- Patients with AF possible reversible causes (pulmonary embolism, acute coronary syndromes, thyrotoxicosis, alcohol abuse, etc.)
- Patients with heart failure in NYHA III-IV stage.
- Patients with life expectancy <1 year.
- Pregnant women.
- Patients who are unable to give consent to participate in the study.
- Patients who do not wish to give written consent to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the ERDAF study (Effect of Renal Denervation on Atrial Fibrillation) is to evaluate the renal sympathetic denervation in patients with resistant arterial hypertension and symptomatic paroxysmal or persistent atrial fibrillation(AF) in order to show if there is a reduction in the AF-related symptoms, the AF recurrence rate, and the total burden (symptomatic and/or asymptomatic) of the arrhythmia. To the best of our knowledge, ERDAF is the first randomized study, which is going to evaluate the effect of RDN [without pulmonary vein isolation (PVI)] on AF recurrence profile and AF ''burden'' using continuous long-term rhythm monitoring via ILRs for a period of 18 months.
Hypothesis
Renal sympathetic denervation in patients with resistant hypertension and symptomatic paroxysmal or persistent atrial fibrillation reduces AF recurrences, total AF "burden" (asymptomatic / symptomatic) and limits the AF-related symptoms.
Read the detailed description
In arterial hypertension (AH), a significant proportion of patients, despite the optimal medical therapy, do not achieve adequate blood pressure (BP) control (resistant hypertension). Renal sympathetic denervation (RDN) is a novel alternative minimally invasive therapeutic option for patients with resistant AH. Recent data has shown that RDN with or without pulmonary vein isolation (PVI) may also have a positive impact on the management of patients with paroxysmal or persistent atrial fibrillation (AF). However, there is no randomized study, to date, suggesting that RDN itself (without PVI) reduces the AF recurrences, symptoms, and the total burden of the arrhythmia. The purpose of this study [Effect of Renal Denervation on Atrial Fibrillation (ERDAF)] is to evaluate the RDN (without PVI) in patients with resistant AH and symptomatic paroxysmal or persistent AF in order to show if there is benefit in the incidence of AF recurrences, the total AF burden (symptomatic and asymptomatic) as well as the BP control. This is a single-center, randomized study in which thirty (30) patients with resistant AH and symptomatic paroxysmal or persistent AF will be randomized (1:1) after sinus rhythm restoration and implantation of an implantable loop recorder (ILR), in either RDN (n=15) or conventional treatment of resistant AH with optimal drug therapy (n=15). Patients will be followed-up every three months and for a period of 18 months after the implantation of the ILR. The first three months after RDN will be excluded from our final analysis (blanking period). The primary endpoint will be the change in the total AF burden (Total time in AF during the follow-up period). Secondary endpoints will include the change in the symptomatic and asymptomatic burden of AF, the time to detect the first AF recurrence (symptomatic and/or asymptomatic)-early recurrence of AF after RDN, and the change in BP during the follow-up period.
- Conditions
- Arterial Hypertension, Atrial Fibrillation
- Being tested
- Sympathetic Renal Denervation, Implantable Loop Recorder
- Keywords
- arterial hypertension, atrial fibrillation, renal denervation, autonomous nervous system, implantable loop recorder, continuous monitoring, burden, insertable cardiac monitor, resistant hypertension
- 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.
Sympathetic Renal DenervationProcedure or surgery
Catheter-based sympathetic renal denervation (RDN) using radiofrequency, ultrasound, or perivascular injection of neurotoxic agents such as alcohol has been introduced as a minimally invasive alternative treatment option for patients with resistant hypertension. RDN consists of endovascular catalysis of the kidney sympathetic nerves running in the wall of the renal arteries.
Implantable Loop RecorderDevice
Also called Insertable Cardiac Monitor
Implantable Loop Recorders (ILRs) are small, subcutaneously implanted devices that are able to detect and store atrial fibrillation episodes lasting longer than 2 minutes with high sensitivity (96.1-100%) and good specificity (67-85.4%) for a period of up to three years.
| Study group | Role | What they receive |
|---|---|---|
| Sympathetic Renal Denervation | Experimental | Sympathetic Renal Denervation Receives: Procedure: Sympathetic Renal Denervation; Device: Implantable Loop Recorder |
| Conventional treatment with drug therapy | Active comparator | Conventional drug therapy of resistant hypertension Receives: Device: Implantable Loop Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the total AF "burden" (symptomatic and asymptomatic AF burden) during the follow-up period.
AF "burden": The amount of time (minutes or hours) the patient is in AF out of the total follow-up period.
Measured: From 3 months to 18 months.The first three months after RDN will be excluded from our final analysis (blanking period)
Secondary outcomes (6)
Change in the symptomatic AF "burden" during the follow-up period.
Symptomatic AF ''burden'': The amount of time (minutes or hours) in which the patient is in AF, perceived by the patient AF, out of the total follow-up period.
Measured: From 3 months to 18 month.The first three months after RDN will be excluded from our final analysis (blanking period)
Change in asymptomatic AF "burden" during the follow-up period.
Asymptomatic AF "burden": The amount of time (minutes or hours) in which the patient is in AF that the patient does not perceive out of the total follow-up period.
Measured: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
The time interval for the detection of the first AF recurrence after the ILR implantation during the follow-up period.
Measured: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
The time interval for detection of the first symptomatic recurrence of the arrhythmia after the ILR implantation during the follow-up period.
Measured: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
Change in blood pressure (systolic, diastolic, and mean blood pressure) as measured by 24-hour ambulatory blood pressure monitoring (ABPM) during the follow-up period.
Measured: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
Change in office blood pressure (systolic, diastolic).
Measured: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Tsioufis, Hippocration General Hospital
- Investigators
- Constantinos P Tsioufis, MD, PhD, Study director, First Cardiology Deparment, Hippokration Hospital, Athens, GreecePanteleimon E Papakonstantinou, MD, PhD, Principal investigator, First Cardiology Deparment, Hippokration Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055285
- Sponsor's protocol ID
- ERDAF
- Acronym
- ERDAF
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.
PubMed 27567465Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014 Jun 16;6:213-20. doi: 10.2147/CLEP.S47385. eCollection 2014.
PubMed 24966695Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
PubMed 30165516Tsioufis C, Ziakas A, Dimitriadis K, Davlouros P, Marketou M, Kasiakogias A, Thomopoulos C, Petroglou D, Tsiachris D, Doumas M, Skalidis E, Karvounis C, Alexopoulos D, Vardas P, Kallikazaros I, Stefanadis C, Papademetriou V, Tousoulis D. Blood pressure response to catheter-based renal sympathetic denervation in severe resistant hypertension: data from the Greek Renal Denervation Registry. Clin Res Cardiol. 2017 May;106(5):322-330. doi: 10.1007/s00392-016-1056-z. Epub 2016 Dec 12.
PubMed 27957627Grassi G, Mark A, Esler M. The sympathetic nervous system alterations in human hypertension. Circ Res. 2015 Mar 13;116(6):976-90. doi: 10.1161/CIRCRESAHA.116.303604.
PubMed 25767284Tsioufis C, Dimitriadis K, Kasiakogias A, Kalos T, Liatakis I, Koutra E, Nikolopoulou L, Kordalis A, Ella RO, Lau EO, Grassi G, Papademetriou V, Tousoulis D. Effects of multielectrode renal denervation on elevated sympathetic nerve activity and insulin resistance in metabolic syndrome. J Hypertens. 2017 May;35(5):1100-1108. doi: 10.1097/HJH.0000000000001262.
PubMed 28106665Simantirakis EN, Papakonstantinou PE, Chlouverakis GI, Kanoupakis EM, Mavrakis HE, Kallergis EM, Arkolaki EG, Vardas PE. Asymptomatic versus symptomatic episodes in patients with paroxysmal atrial fibrillation via long-term monitoring with implantable loop recorders. Int J Cardiol. 2017 Mar 15;231:125-130. doi: 10.1016/j.ijcard.2016.12.025. Epub 2016 Dec 21.
PubMed 28041713Bettoni M, Zimmermann M. Autonomic tone variations before the onset of paroxysmal atrial fibrillation. Circulation. 2002 Jun 11;105(23):2753-9. doi: 10.1161/01.cir.0000018443.44005.d8.
PubMed 12057990Lombardi F, Tarricone D, Tundo F, Colombo F, Belletti S, Fiorentini C. Autonomic nervous system and paroxysmal atrial fibrillation: a study based on the analysis of RR interval changes before, during and after paroxysmal atrial fibrillation. Eur Heart J. 2004 Jul;25(14):1242-8. doi: 10.1016/j.ehj.2004.05.016.
PubMed 15246643Papademetriou V, Doumas M, Tsioufis K. Renal Sympathetic Denervation for the Treatment of Difficult-to-Control or Resistant Hypertension. Int J Hypertens. 2011;2011:196518. doi: 10.4061/2011/196518. Epub 2011 Mar 30.
PubMed 21629864Pokushalov 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.
PubMed 22958958Vollmann D, Sossalla S, Schroeter MR, Zabel M. Renal artery ablation instead of pulmonary vein ablation in a hypertensive patient with symptomatic, drug-resistant, persistent atrial fibrillation. Clin Res Cardiol. 2013 Apr;102(4):315-8. doi: 10.1007/s00392-012-0529-y. Epub 2012 Dec 14. No abstract available.
PubMed 23239408Qiu M, Yin Y, Shan Q. Renal sympathetic denervation versus antiarrhythmic drugs for drug-resistant hypertension and symptomatic atrial fibrillation (RSDforAF) trial: study protocol for a randomized controlled trial. Trials. 2013 Jun 11;14:168. doi: 10.1186/1745-6215-14-168.
PubMed 23759000Feyz L, Theuns DA, Bhagwandien R, Strachinaru M, Kardys I, Van Mieghem NM, Daemen J. Atrial fibrillation reduction by renal sympathetic denervation: 12 months' results of the AFFORD study. Clin Res Cardiol. 2019 Jun;108(6):634-642. doi: 10.1007/s00392-018-1391-3. Epub 2018 Nov 10.
PubMed 30413869Kosiuk Md J, Pokushalov Md Phd E, Hilbert Md S, Hindricks Md G, Bollmann Md PhD A, S Steinberg Md J. The Role of Renal Sympathetic Denervation in Atrial Fibrillation. J Atr Fibrillation. 2014 Feb 28;6(5):987. doi: 10.4022/jafib.987. eCollection 2014 Feb-Mar.
PubMed 27957040
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Renal Denervation on Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04055285
- Acronym / sponsor ID
- ERDAF / ERDAF
- Conditions
- Arterial Hypertension, Atrial Fibrillation
- Keywords
- arterial hypertension, atrial fibrillation, renal denervation, autonomous nervous system, implantable loop recorder, continuous monitoring, burden, insertable cardiac monitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Aug 2019 (actual)
- 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 the ERDAF study (Effect of Renal Denervation on Atrial Fibrillation) is to evaluate the renal sympathetic denervation in patients with resistant arterial hypertension and symptomatic paroxysmal or persistent atrial fibrillation(AF) in order to show if there is a reduction in the AF-related symptoms, the AF recurrence rate, and the total burden (symptomatic and/or asymptomatic) of the arrhythmia. To the best of our knowledge, ERDAF is the first randomized study, which is going to evaluate the effect of RDN [without pulmonary vein isolation (PVI)] on AF recurrence profile and AF ''burden'' using continuous long-term rhythm monitoring via ILRs for a period of 18 months.
Hypothesis
Renal sympathetic denervation in patients with resistant hypertension and symptomatic paroxysmal or persistent atrial fibrillation reduces AF recurrences, total AF "burden" (asymptomatic / symptomatic) and limits the AF-related symptoms.
Detailed description
In arterial hypertension (AH), a significant proportion of patients, despite the optimal medical therapy, do not achieve adequate blood pressure (BP) control (resistant hypertension). Renal sympathetic denervation (RDN) is a novel alternative minimally invasive therapeutic option for patients with resistant AH. Recent data has shown that RDN with or without pulmonary vein isolation (PVI) may also have a positive impact on the management of patients with paroxysmal or persistent atrial fibrillation (AF). However, there is no randomized study, to date, suggesting that RDN itself (without PVI) reduces the AF recurrences, symptoms, and the total burden of the arrhythmia. The purpose of this study [Effect of Renal Denervation on Atrial Fibrillation (ERDAF)] is to evaluate the RDN (without PVI) in patients with resistant AH and symptomatic paroxysmal or persistent AF in order to show if there is benefit in the incidence of AF recurrences, the total AF burden (symptomatic and asymptomatic) as well as the BP control. This is a single-center, randomized study in which thirty (30) patients with resistant AH and symptomatic paroxysmal or persistent AF will be randomized (1:1) after sinus rhythm restoration and implantation of an implantable loop recorder (ILR), in either RDN (n=15) or conventional treatment of resistant AH with optimal drug therapy (n=15). Patients will be followed-up every three months and for a period of 18 months after the implantation of the ILR. The first three months after RDN will be excluded from our final analysis (blanking period). The primary endpoint will be the change in the total AF burden (Total time in AF during the follow-up period). Secondary endpoints will include the change in the symptomatic and asymptomatic burden of AF, the time to detect the first AF recurrence (symptomatic and/or asymptomatic)-early recurrence of AF after RDN, and the change in BP during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sympathetic Renal Denervation | Experimental | Procedure: Sympathetic Renal Denervation, Device: Implantable Loop RecorderSympathetic Renal Denervation |
| Conventional treatment with drug therapy | Active comparator | Device: Implantable Loop RecorderConventional drug therapy of resistant hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years with resistant hypertension [Systolic Blood Pressure (SBP) ≥ 140 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 90 mmHg despite treatment with ≥ 3 antihypertensive drugs of various classes, including a diuretic) and symptomatic paroxysmal or persistent AF will be included in the study after sinus rhythm restoration
Key exclusion criteria (14 listed)
- Patients with permanent AF or patients with long-standing persistent AF as defined by the current ESC guidelines for the management of AF1.
- Patients with a glomerular filtration rate (eGFR)] <45 ml / min / 1.73 m2 calculated using the CKD-EPI43.
- Patients with secondary arterial hypertension.
- Patients with an established diagnosis of resistant hypertension <6 months.
- Patients with severe renal artery stenosis or previous renal artery angioplasty.
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 |
|---|---|---|
| Sympathetic Renal DenervationCatheter-based sympathetic renal denervation (RDN) using radiofrequency, ultrasound, or perivascular injection of neurotoxic agents such as alcohol has been introduced as a minimally invasive alternative treatment option for patients with resistant hypertension. RDN consists of endovascular catalysis of the kidney sympathetic nerves running in the wall of the renal arteries. | Procedure or surgery | Sympathetic Renal Denervation |
| Implantable Loop RecorderAlso: Insertable Cardiac MonitorImplantable Loop Recorders (ILRs) are small, subcutaneously implanted devices that are able to detect and store atrial fibrillation episodes lasting longer than 2 minutes with high sensitivity (96.1-100%) and good specificity (67-85.4%) for a period of up to three years. | Device | Conventional treatment with drug therapy, Sympathetic Renal Denervation |
Primary outcome
The change in the total AF "burden" (symptomatic and asymptomatic AF burden) during the follow-up period.
Time frame: From 3 months to 18 months.The first three months after RDN will be excluded from our final analysis (blanking period)
AF "burden": The amount of time (minutes or hours) the patient is in AF out of the total follow-up period.
6 secondary outcomes
Change in the symptomatic AF "burden" during the follow-up period.
Time frame: From 3 months to 18 month.The first three months after RDN will be excluded from our final analysis (blanking period)
Change in asymptomatic AF "burden" during the follow-up period.
Time frame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
The time interval for the detection of the first AF recurrence after the ILR implantation during the follow-up period.
Time frame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
The time interval for detection of the first symptomatic recurrence of the arrhythmia after the ILR implantation during the follow-up period.
Time frame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
Change in blood pressure (systolic, diastolic, and mean blood pressure) as measured by 24-hour ambulatory blood pressure monitoring (ABPM) during the follow-up period.
Time frame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
Change in office blood pressure (systolic, diastolic).
Time frame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 27567465Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.
- Background: PubMed 24966695Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014 Jun 16;6:213-20. doi: 10.2147/CLEP.S47385. eCollection 2014.
- Background: PubMed 30165516Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
- Background: PubMed 27957627Tsioufis C, Ziakas A, Dimitriadis K, Davlouros P, Marketou M, Kasiakogias A, Thomopoulos C, Petroglou D, Tsiachris D, Doumas M, Skalidis E, Karvounis C, Alexopoulos D, Vardas P, Kallikazaros I, Stefanadis C, Papademetriou V, Tousoulis D. Blood pressure response to catheter-based renal sympathetic denervation in severe resistant hypertension: data from the Greek Renal Denervation Registry. Clin Res Cardiol. 2017 May;106(5):322-330. doi: 10.1007/s00392-016-1056-z. Epub 2016 Dec 12.
- Background: PubMed 25767284Grassi G, Mark A, Esler M. The sympathetic nervous system alterations in human hypertension. Circ Res. 2015 Mar 13;116(6):976-90. doi: 10.1161/CIRCRESAHA.116.303604.
- Background: PubMed 28106665Tsioufis C, Dimitriadis K, Kasiakogias A, Kalos T, Liatakis I, Koutra E, Nikolopoulou L, Kordalis A, Ella RO, Lau EO, Grassi G, Papademetriou V, Tousoulis D. Effects of multielectrode renal denervation on elevated sympathetic nerve activity and insulin resistance in metabolic syndrome. J Hypertens. 2017 May;35(5):1100-1108. doi: 10.1097/HJH.0000000000001262.
- Background: PubMed 28041713Simantirakis EN, Papakonstantinou PE, Chlouverakis GI, Kanoupakis EM, Mavrakis HE, Kallergis EM, Arkolaki EG, Vardas PE. Asymptomatic versus symptomatic episodes in patients with paroxysmal atrial fibrillation via long-term monitoring with implantable loop recorders. Int J Cardiol. 2017 Mar 15;231:125-130. doi: 10.1016/j.ijcard.2016.12.025. Epub 2016 Dec 21.
- Background: PubMed 12057990Bettoni M, Zimmermann M. Autonomic tone variations before the onset of paroxysmal atrial fibrillation. Circulation. 2002 Jun 11;105(23):2753-9. doi: 10.1161/01.cir.0000018443.44005.d8.
- Background: PubMed 15246643Lombardi F, Tarricone D, Tundo F, Colombo F, Belletti S, Fiorentini C. Autonomic nervous system and paroxysmal atrial fibrillation: a study based on the analysis of RR interval changes before, during and after paroxysmal atrial fibrillation. Eur Heart J. 2004 Jul;25(14):1242-8. doi: 10.1016/j.ehj.2004.05.016.
- Background: PubMed 21629864Papademetriou V, Doumas M, Tsioufis K. Renal Sympathetic Denervation for the Treatment of Difficult-to-Control or Resistant Hypertension. Int J Hypertens. 2011;2011:196518. doi: 10.4061/2011/196518. Epub 2011 Mar 30.
- Background: PubMed 22958958Pokushalov 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.
- Background: PubMed 23239408Vollmann D, Sossalla S, Schroeter MR, Zabel M. Renal artery ablation instead of pulmonary vein ablation in a hypertensive patient with symptomatic, drug-resistant, persistent atrial fibrillation. Clin Res Cardiol. 2013 Apr;102(4):315-8. doi: 10.1007/s00392-012-0529-y. Epub 2012 Dec 14. No abstract available.
- Individual participant dataSharing planned: No
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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.
Constantinos P Tsioufis, MD, PhD study director
First Cardiology Deparment, Hippokration Hospital, Athens, Greece
Panteleimon E Papakonstantinou, MD, PhD principal investigator
First Cardiology Deparment, Hippokration Hospital, Athens, Greece
Questions about this trial
What is this clinical trial studying?
A study testing Sympathetic Renal Denervation and Implantable Loop Recorder in people with Arterial Hypertension and Atrial Fibrillation, run by Hippocration General Hospital.
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 1 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Constantinos P Tsioufis, MD, PhD (+30 2132088386, ktsioufis@hippocratio.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the total AF "burden" (symptomatic and asymptomatic AF burden) during the follow-up period. (time frame: From 3 months to 18 months.The first three months after RDN will be excluded from our final analysis (blanking period)). 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 NCT04055285, which also lists 20 linked publications.
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 13 Aug 2019.