Supportive Treatment of Severe Heart Failure by Renal Denervation

Study Overview
=================
Brief Summary
-----------------
The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.

Detailed Description
-----------------
The patient population consists of heart failure patients who are not responding properly to medication and biventricular pacing therapy. The inappropriate response to these therapies is evaluated by patient history (NYHA III-IV), echocardiography (EF < 45%), 6-minute walking test (<440m) and measurements of P-ProBNP. The patients who fulfill the inclusion criteria will undergo renal nervous denervation. The patients will be followed up with the same methods as they were recruited to the study (by patient history (NYHA III-IV), echocardiography (EF < 45%), 6-minute walking test (<440m) and measurements of P-ProBNP). The overall time of follow-up will be 24 months. The patients are randomised according to the waiting list principle in a manner to 1:1. The waiting time will be 6 months.

Official Title
-----------------
Supportive Treatment of Severe Heart Failure by Renal Denervation

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Renal nervous denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NYHA III-IV ejection fraction <45 % 6-minute walking test under 440m Exclusion Criteria: Unstable hemodynamic state uncooperation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renal nervous denervation.<br>Renal nervous denervation is performed to the patients who do not response properly to conventional therapy. The patients are randomised according to the waiting list principle. | Procedure: Renal nervous denervation<br>* The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.<br>|
| Active Comparator: Renal nervous denervation (delayed)<br>Renal nervous denervation is performed after six months on the waiting list | Procedure: Renal nervous denervation<br>* The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walking test | Composite outcome measure | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient history | Composite outcome measure | 24 months | 
| Cardiac echocardiography | Composite outcome measure | 24 months | 
| P-proBNP | Composite outcome measure | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal nervous denervation