REDUCE-CAD
Research type
Research Study
Full title
Renal Denervation using a multielectrode balloon Catheter for patients with resistant hypertension and Chronic heart failure, Arrhythmia, or Diabetes (REDUCE-CAD)
IRAS ID
153174
Contact name
Ian Menown
Contact email
Sponsor organisation
Southern Trust
Research summary
Selective catheter-based radiofrequency ablation of the renal nerves which lie within the wall of the renal artery and involved in mechanisms leading to elevated blood pressure has been shown to be a potentially useful treatment for resistant hypertension. The Vessix renal denervation catheter (Boston Scientific Corporation, Natick, MA) comprises a low pressure balloon with 2 pairs of bi-polar low wattage electrodes arranged in helical fashion on the balloon surface providing a helical arrangement of 4 ablation points. Compared with first generation single electrode devices, the design enables a much shorter ablation time (30 seconds per 4 electrode application) and potentially less patient discomfort. Interim six months results from 139 of 145 enrolled patients in the REDUCE-HTN trial presented at TCT Oct 2013 reported an office blood pressure reduction of 24.6/10.3mmHg and ambulatory blood pressure reduction of 11.2/6.3mmHg.
Patients with resistant hypertension often have associated comorbidities, some of which may also benefit from reduction of excessive sympathetic drive achieved through RDT such as chronic heart failure atrial rhythm disturbance or diabetes.
We propose to study 100 patients from approximately 10 hospitals with resistant hypertension undergoing RDT with the CE marked Vessix catheter according to standard clinical practice, who have one or more comorbidities from congestive heart failure, atrial rhythm disturbance or diabetes. Standard outpatient clinic follow up will be undertaken to assess blood pressure and other clinical outcomes.
REC name
HSC REC B
REC reference
14/NI/0085
Date of REC Opinion
1 Jul 2014
REC opinion
Further Information Favourable Opinion