Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: renal denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 pregnancy 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>Renal denervation | Procedure: renal denervation<br> <br> |
| No Intervention: Observational<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal denervation