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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

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE August 13, 2019
Last Update Posted Date August 13, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • 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.
  • 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.
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Renal Denervation on Atrial Fibrillation
Official Title  ICMJE Effect of Renal Denervation on Atrial Fibrillation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Arterial Hypertension
  • Atrial Fibrillation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Sympathetic Renal Denervation
    Sympathetic Renal Denervation
    Interventions:
    • Procedure: Sympathetic Renal Denervation
    • Device: Implantable Loop Recorder
  • Active Comparator: Conventional treatment with drug therapy
    Conventional drug therapy of resistant hypertension
    Intervention: Device: Implantable Loop Recorder
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Constantinos P Tsioufis, MD, PhD +30 2132088386 ktsioufis@hippocratio.gr
Contact: Panteleimon E Papakonstantinou, MD, PhD +30 6948050600 pantelispapakon@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04055285
Other Study ID Numbers  ICMJE ERDAF
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Konstantinos Tsioufis, Hippocration General Hospital
Study Sponsor  ICMJE Hippocration General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hippocration General Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP