Supportive Treatment of Severe Heart Failure by Renal Denervation

NCT ID: NCT02638324

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2019-01-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Renal nervous denervation

Intervention Type: PROCEDURE

The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.

Renal nervous denervation (delayed)

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

Group Type: ACTIVE_COMPARATOR

Renal nervous denervation

Intervention Type: PROCEDURE

The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.

Interventions

Renal nervous denervation

The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Unstable hemodynamic state
• uncooperation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satakunta Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mari-Anne Vaittinen, MD

Role: STUDY_CHAIR

Vaasa Central Hospitla

Mari-Anne Vaittinen, MD

Role: STUDY_CHAIR

Vaasa Central Hospital, Vaasa, Finland

Locations

Vaasa Central Hospital

Vaasa, , Finland

Countries

Finland

Other Identifiers

Juhani02

Identifier Type: -

Identifier Source: org_study_id