Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
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ClinicalTrials.gov Identifier: NCT02329145
Recruitment Status : Unknown
Verified December 2014 by Aleksander Kusiak, Jagiellonian University. Recruitment status was: Recruiting
Chronic heart failure is becoming more and more common disease and activation of sympathetic nervous system plays a crucial role in its development. There is some data allowing to suspect that one of the new treatment methods- renal denervation, also in patients with chronic heart failure may lead to decrease of systemic activity sympathetic nervous system and, as a consequence, to decrease of disease progression. The research hypothesis is whether renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is used (including resynchronization therapy), is contributing to the improvement in parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far only very limited data- mostly case reports- are available in this study area.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
age ≥ 18 year
heart failure patients NYHA Class II - IV
implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
left ventricular ejection function ≤ 35%
glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
patient informed consent for participation in the study
renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
history of prior renal artery intervention
single functioning kidney
clinic systolic BP < 110mmHg
acute coronary syndrome or cerebrovascular event within last 3 months
serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)