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Effect of Renal Denervation on Atrial Fibrillation (ERDAF)

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ClinicalTrials.gov Identifier: NCT04055285
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Konstantinos Tsioufis, Hippocration General Hospital

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.


Condition or disease Intervention/treatment Phase
Arterial Hypertension Atrial Fibrillation Procedure: Sympathetic Renal Denervation Device: Implantable Loop Recorder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Renal Denervation on Atrial Fibrillation
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sympathetic Renal Denervation
Sympathetic Renal Denervation
Procedure: Sympathetic Renal Denervation
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.

Device: Implantable Loop Recorder
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.
Other Name: Insertable Cardiac Monitor

Active Comparator: Conventional treatment with drug therapy
Conventional drug therapy of resistant hypertension
Device: Implantable Loop Recorder
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.
Other Name: Insertable Cardiac Monitor




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055285


Contacts
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Contact: Constantinos P Tsioufis, MD, PhD +30 2132088386 ktsioufis@hippocratio.gr
Contact: Panteleimon E Papakonstantinou, MD, PhD +30 6948050600 pantelispapakon@gmail.com

Sponsors and Collaborators
Hippocration General Hospital
Investigators
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Study Director: Constantinos P Tsioufis, MD, PhD First Cardiology Deparment, Hippokration Hospital, Athens, Greece
Principal Investigator: Panteleimon E Papakonstantinou, MD, PhD First Cardiology Deparment, Hippokration Hospital, Athens, Greece

Publications:

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Responsible Party: Konstantinos Tsioufis, Professor of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Hippocration General Hospital
ClinicalTrials.gov Identifier: NCT04055285     History of Changes
Other Study ID Numbers: ERDAF
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Konstantinos Tsioufis, Hippocration General Hospital:
arterial hypertension
atrial fibrillation
renal denervation
autonomous nervous system
implantable loop recorder
continuous monitoring
burden
insertable cardiac monitor
resistant hypertension
Additional relevant MeSH terms:
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Hypertension
Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes