Supportive Treatment of Severe Heart Failure by Renal Denervation (Heart-RND)

Turku University Hospital (TYKS)

Status: Terminated

Conditions: Heart Failure

Treatments: Procedure: Renal nervous denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02638324

Juhani02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NYHA III-IV
• ejection fraction <45 %
• 6-minute walking test under 440m

Exclusion criteria

• Unstable hemodynamic state
• uncooperation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Renal nervous denervation.

Active Comparator group

Description:

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.

Treatment:

Procedure: Renal nervous denervation

Renal nervous denervation (delayed)

Active Comparator group

Description:

Renal nervous denervation is performed after six months on the waiting list

Treatment:

Procedure: Renal nervous denervation