Heart Failure
Conditions
Keywords
renal denervation
Brief summary
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.
Interventions
PROCEDURErenal denervation
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 year 2. heart failure patients NYHA Class II - IV 3. implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier 4. symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure) 5. left ventricular ejection function ≤ 35% 6. glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2) 7. patient informed consent for participation in the study
Exclusion criteria
1. renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length) 2. history of prior renal artery intervention 3. single functioning kidney 4. clinic systolic BP \< 110mmHg 5. pregnancy 6. acute coronary syndrome or cerebrovascular event within last 3 months 7. serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hospitalizations due to heart failure worsening. | one year |
| Change in NYHA class. | one year |
| Change in 6 minute walk test distance. | one year |
Countries
Poland
Contacts
Primary ContactAleksander Kusiak, PhD,MD
Outcome results
None listed