This pilot study located in South Africa aims to study whether renal artery denervation can reduce blood pressure and prevent atrial fibrillation (abnormal heart rhythm). The outcome to be measured is the presence/absence of atrial fibrillation.
The details
Renal artery denervation is a new procedure that uses electrical current to destroy the nerves of arteries of the kidney. Studies have shown that renal artery denervation effectively reduces blood pressure in up to 80% of patients. This reduction of blood pressure leads improvement of heart function. Hence, it is suggested that renal artery denervation could prevent atrial fibrillation.
Who are they looking for?
This trial is recruiting 100 patients aged 55 years and older who, for reasons including (but not limited to) acute coronary syndrome, abnormal ECG result, blood pressure in the doctors office of >160/90 mmHg (>150/90 mmHg for diabetics), must undergo a coronary angiography (x-ray that examines blood vessels). Patients should not have substantially narrowed heart valves. Patients should not need to undergo coronary artery bypass surgery.
How will it work
Patients will be randomly assigned to one of two treatment groups.
The first group of patients will receive renal denervation to both blood vessels of the kidney. The second group of patients will receive a placebo (procedure with no real effect) renal denervation for comparison. All patients will also continue on their standard medical therapy as prescribed by their treating physician. Medical therapy would include drugs treating high blood pressure. Coronary angiography may be performed and a Reveal® holter (device that measures activity of the heart) will be implanted in all patients at the end of the procedure. Patients will be followed up for three years.
