Clinical trial NCT04055285: Effect of Renal Denervation on Atrial Fibrillation
Official title: Effect of Renal Denervation on Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arterial Hypertension
Atrial Fibrillation
Keywords: arterial hypertension
atrial fibrillation
renal denervation
autonomous nervous system
implantable loop recorder
continuous monitoring
burden
insertable cardiac monitor
resistant hypertension
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with permanent AF or patients with long-standing persistent AF as defined by the current ESC guidelines for the management of AF1.
2. Patients with a glomerular filtration rate (eGFR)\] \<45 ml / min / 1.73 m2 calculated using the CKD-EPI43.
3. Patients with secondary arterial hypertension.
4. Patients with an established diagnosis of resistant hypertension \<6 months.
5. Patients with severe renal artery stenosis or previous renal artery angioplasty.
6. Patients who have undergone or are about to undergo pulmonary vein isolation.
7. Patients with left end-diastolic ventricle diameter \>60 mm in men or \>55mm in women.
8. Patients with a left ventricular ejection fraction \<35% in the transthoracic echocardiogram (TTE).
9. Patients with AF possible reversible causes (pulmonary embolism, acute coronary syndromes, thyrotoxicosis, alcohol abuse, etc.)
10. Patients with heart failure in NYHA III-IV stage.
11. Patients with life expectancy \<1 year.
12. Pregnant women.
13. Patients who are unable to give consent to participate in the study.
14. Patients who do not wish to give written consent to participate in the study.

Primary outcomes:
measure: The change in the total AF "burden" (symptomatic and asymptomatic AF burden) during the follow-up period.
timeFrame: From 3 months to 18 months.The first three months after RDN will be excluded from our final analysis (blanking period)
Secondary outcomes:
measure: Change in the symptomatic AF "burden" during the follow-up period.
timeFrame: From 3 months to 18 month.The first three months after RDN will be excluded from our final analysis (blanking period)
measure: Change in asymptomatic AF "burden" during the follow-up period.
timeFrame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
measure: The time interval for the detection of the first AF recurrence after the ILR implantation during the follow-up period.
timeFrame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
measure: The time interval for detection of the first symptomatic recurrence of the arrhythmia after the ILR implantation during the follow-up period.
timeFrame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
measure: 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.
timeFrame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
measure: Change in office blood pressure (systolic, diastolic).
timeFrame: From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)
Other outcomes:
Locations:
Study officials:
affiliation: First Cardiology Deparment, Hippokration Hospital, Athens, Greece
name: Constantinos P Tsioufis, MD, PhD
role: STUDY_DIRECTOR
affiliation: First Cardiology Deparment, Hippokration Hospital, Athens, Greece
name: Panteleimon E Papakonstantinou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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