Supportive Treatment of Severe Heart Failure by Renal Denervation

Not Applicable

Terminated

• Conditions: Heart Failure
• Interventions: Procedure: Renal nervous denervation

• Registration Number: NCT02638324
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-23
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Unstable hemodynamic state
• uncooperation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal nervous denervation.	Renal nervous denervation	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)	Renal nervous denervation	Renal nervous denervation is performed after six months on the waiting list

Primary Outcome Measures

Name	Time	Method
6-minute walking test	24 months	Composite outcome measure

Secondary Outcome Measures

Name	Time	Method
Cardiac echocardiography	24 months	Composite outcome measure
Patient history	24 months	Composite outcome measure
P-proBNP	24 months	Composite outcome measure

Trial Locations

Locations (1)

Vaasa Central Hospital; 🇫🇮 Vaasa, Finland