Supportive Treatment of Severe Heart Failure by Renal Denervation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Turku University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 6-minute walking test
- Status
- Terminated
- Last Updated
- 5 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •NYHA III-IV
- •ejection fraction \<45 %
- •6-minute walking test under 440m
Exclusion Criteria
- •Unstable hemodynamic state
- •uncooperation
Outcomes
Primary Outcomes
6-minute walking test
Time Frame: 24 months
Composite outcome measure
Secondary Outcomes
- Cardiac echocardiography(24 months)
- Patient history(24 months)
- P-proBNP(24 months)