Ashley Chin1, Mpiko Ntsekhe1, Charle Viljoen1, Johan Rossouw2, Tim Pennel2, Peter J Schwartz3. 1. Division of Cardiology, Department of Medicine, University of Cape Town, Groote Schuur Hospital, Cape Town, South Africa. 2. Christiaan Barnard Division of Cardiothoracic Surgery, Faculty of Health Sciences, University of Cape Town, 7925, Observatory, Cape Town, South Africa. 3. Division of Cardiology, Department of Medicine, University of Cape Town, Groote Schuur Hospital, Cape Town, South Africa; IRCCS Istituto Auxologico Italiano, Center for Cardiac Arrhythmias of Genetic Origin and Laboratory of Cardiovascular Genetics, Milan, Italy. Electronic address: peter.schwartz@unipv.it.
Abstract
BACKGROUND: The main causes of mortality in patients with chronic heart failure include sudden cardiac death (SCD) and progressive heart failure. Autonomic dysfunction plays a detrimental role in the progression of chronic heart failure. Left cardiac sympathetic denervation (LCSD) is an inexpensive and safe procedure which modifies autonomic innervation of the heart and is associated with a significant antifibrillatory effect. Whether LCSD reduces the risk of SCD, delays progression of heart failure and improves quality of life in patients with heart failure with reduced ejection fraction (HFrEF) is not known. METHODS AND DESIGN: This is a 2-phased prospective, randomized trial to test the efficacy and safety of LCSD as an adjunct to guideline recommended medical therapy for patients with HFrEF. Once the safety and feasibility of conducting a large LCSD study have been demonstrated in the pilot phase, a phase III efficacy trial to assess the impact on ventricular arrhythmias, heart failure outcomes, and mortality will be completed. Outcome data from the pilot study will remain blinded and added to the results of phase III study for analysis. RESULTS: To date the study has received approval from local and national ethics and regulatory bodies and recruitment has commenced, and 4 patients have been randomized so far. CONCLUSION: If LCSD is proven to be safe, feasible and effective in this first ever study using this novel approach in patients with HFrEF it may be a cost-effective alternative to the implantable cardioverter defibrillator therapy especially in regions where ICDs and cardiac transplantation are unavailable.
RCT Entities:
BACKGROUND: The main causes of mortality in patients with chronic heart failure include sudden cardiac death (SCD) and progressive heart failure. Autonomic dysfunction plays a detrimental role in the progression of chronic heart failure. Left cardiac sympathetic denervation (LCSD) is an inexpensive and safe procedure which modifies autonomic innervation of the heart and is associated with a significant antifibrillatory effect. Whether LCSD reduces the risk of SCD, delays progression of heart failure and improves quality of life in patients with heart failure with reduced ejection fraction (HFrEF) is not known. METHODS AND DESIGN: This is a 2-phased prospective, randomized trial to test the efficacy and safety of LCSD as an adjunct to guideline recommended medical therapy for patients with HFrEF. Once the safety and feasibility of conducting a large LCSD study have been demonstrated in the pilot phase, a phase III efficacy trial to assess the impact on ventricular arrhythmias, heart failure outcomes, and mortality will be completed. Outcome data from the pilot study will remain blinded and added to the results of phase III study for analysis. RESULTS: To date the study has received approval from local and national ethics and regulatory bodies and recruitment has commenced, and 4 patients have been randomized so far. CONCLUSION: If LCSD is proven to be safe, feasible and effective in this first ever study using this novel approach in patients with HFrEF it may be a cost-effective alternative to the implantable cardioverter defibrillator therapy especially in regions where ICDs and cardiac transplantation are unavailable.