Status:
UNKNOWN
Effect of Renal Denervation on Atrial Fibrillation
Lead Sponsor:
Hippocration General Hospital
Conditions:
Arterial Hypertension
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 pa...
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 sympatheti...
Eligibility Criteria
Inclusion
- Patients \>18 years with resistant hypertension \[Systolic Blood Pressure (SBP) ≥ 140 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 90 mmHg despite treatment with ≥ 3 antihypertensive drugs of various classes, including a diuretic) and symptomatic paroxysmal or persistent AF will be included in the study after sinus rhythm restoration
Exclusion
- Patients with permanent AF or patients with long-standing persistent AF as defined by the current ESC guidelines for the management of AF1.
- Patients with a glomerular filtration rate (eGFR)\] \<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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04055285
Start Date
January 1 2020
End Date
December 31 2022
Last Update
August 13 2019
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