Renal Sympathetic Denervation Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The autonomic nervous system plays an important role in the precipitation of AF in structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent new-onset AF.

Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and improvement of diastolic dysfunction follow as a consequence of afterload reduction and renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci originate.

Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by reducing afterload. These synergistic mechanisms may prevent new-onset AF.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pace Clinic
• Collaborator: University Hospital, Saarland
• Treatments: Diuretics

Criteria

Inclusion Criteria:

• Must have an indication for coronary angiography e.g.

• Acute coronary syndrome

• Positive stress ECG: - Defined as ≥1mm ST segment shift (depression or elevation) in ≥2 contiguous leads with/without chest discomfort)

• Age ≥55 years

• Office blood pressure ≥160/90mmHg in non-diabetics or ≥150/90mmHg in diabetics

• Subjects must be on at least 3 anti-hypertensive drugs, including a diuretic agent

• Sinus rhythm

• Left ventricular hypertrophy defined on echo as:

• Estimated LV mass > 255 g or LVMI >131 g/m2 for men

• Estimated LV mass >193 g or LVMI >113 g/m2for women

• Left atrial diameter ≥45mm on any echocardiographic window

Exclusion Criteria:

• Estimated glomerular filtration rate (eGFR) < 45ml/min/1.73m2

• Renal artery anatomy unsuitable for RDN

• Substantial stenotic valvular heart disease

• Pregnancy or planned pregnancy

• Thyrotoxicosis

• Patients needing to undergo coronary artery bypass surgery