Atrial Fibrillation Clinical Trial
— ERDAFOfficial title:
Effect of Renal Denervation on Atrial Fibrillation
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hippocration General Hospital |
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | From 3 months to 18 month.The first three months after RDN will be excluded from our final analysis (blanking period) | |
Secondary | 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. | From 3 months to 18 months. The first three months after RDN will be excluded from our final analysis (blanking period) | |
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | Change in office blood pressure (systolic, diastolic). | 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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