Effect of Renal Denervation on Atrial Fibrillation

NCT04055285 | Unknown

• 1 other identifier: ERDAF
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  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.

  From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period)

Study Arms (2)

Sympathetic Renal Denervation

EXPERIMENTAL

Sympathetic Renal Denervation

Procedure: Sympathetic Renal Denervation; Device: Implantable Loop Recorder

Conventional treatment with drug therapy

ACTIVE COMPARATOR

Conventional drug therapy of resistant hypertension

Device: Implantable Loop Recorder

Interventions

Sympathetic Renal Denervation PROCEDURE

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.

Sympathetic Renal Denervation

Implantable Loop Recorder DEVICE

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.

Also known as: Insertable Cardiac Monitor

Conventional treatment with drug therapy; Sympathetic Renal Denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hippocration General Hospital: lead

Related Publications (20)

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MeSH Terms

Conditions

Hypertension; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Constantinos P Tsioufis, MD, PhD

  First Cardiology Deparment, Hippokration Hospital, Athens, Greece

  STUDY DIRECTOR

• Panteleimon E Papakonstantinou, MD, PhD

  First Cardiology Deparment, Hippokration Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constantinos P Tsioufis, MD, PhD

CONTACT

+30 2132088386; ktsioufis@hippocratio.gr

Panteleimon E Papakonstantinou, MD, PhD

CONTACT

+30 6948050600; pantelispapakon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, School of Medicine, National and Kapodistrian University of Athens

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share