The renin-angiotensin-aldosterone axis has been found to be a key system involved in heart failure disease progression and it may be inhibited by renal sympathetic denervation. Therefore, a clear need exists for further strategies to beneficially manipulate the sympathetic activation that is characteristic of the heart failure disease process. The combined experience in the pilot studies and the EU randomized, controlled study indicates that the Paradise Catheter System can safely denervate renal sympathetic nerves of the kidney without significant periprocedural complications. Preliminary results of a pilot study of catheter-based renal denervation in a small number of CHF patients did not show evidence of safety issues but suggest improvements in CHF symptoms. This trial will explore the safety and feasibility of renal denervation in a significantly higher number of patients with chronic heart failure. Both inter-individual and intra-individual controls will be used in order to obtain sufficient data and to in order to enable both treatment and control group to receive renal denervation. Additionally, this feasibility trial to describe the safety and feasibility of renal denervation in patients with elevated sympathetic activity as in patients with chronic heart failure, will further the understanding of the role of renal nerves in the control of chronic heart failure and the pathogenesis of both ventricular remodeling and cardio-renal syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
Renal arteriography followed by renal denervation
Renal arteriography only
Saarland University Medical Center, Department for Internal Medicine III
Homburg/Saar, Saarland, Germany
6 Minute Walk Test
Change in 6-min walk distance
Time frame: 6 months
NT-proBNP
Change in plasma NT-proBNP values
Time frame: 6 months
KCCQ
Change in Overall Summary Score measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 6 months
EQ-5D
Change in Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnea score
Time frame: 6 months
eGFR
chronic eGFR slope defined as eCRF
Time frame: 6 months
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