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Because of the lack of the candidates and because of restrictions of denervation at the completion date.
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| Name | Class |
|---|---|
| Satakunta Central Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal nervous denervation. | Active Comparator | 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. |
|
| Renal nervous denervation (delayed) | Active Comparator | Renal nervous denervation is performed after six months on the waiting list |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal nervous denervation | Procedure | The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walking test | Composite outcome measure | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient history | Composite outcome measure | 24 months |
| Cardiac echocardiography | Composite outcome measure | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mari-Anne Vaittinen, MD | Vaasa Central Hospitla | Study Chair |
| Mari-Anne Vaittinen, MD | Vaasa Central Hospital, Vaasa, Finland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaasa Central Hospital | Vaasa | 65130 | Finland |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| P-proBNP | Composite outcome measure | 24 months |