Supportive Treatment of Severe Heart Failure by Renal Denervation

Heart Failure Clinical Trial

— Heart-RND  

Official title:

Supportive Treatment of Severe Heart Failure by Renal Denervation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02638324
• Other study ID #: Juhani02
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2014
• Est. completion date: January 30, 2019

Study information

• Verified date: March 2021
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• NYHA III-IV

• ejection fraction <45 %

• 6-minute walking test under 440m

Exclusion Criteria:

• Unstable hemodynamic state

• uncooperation

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Finland	Vaasa Central Hospital	Vaasa

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Satakunta Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walking test	Composite outcome measure	24 months
Secondary	Patient history	Composite outcome measure	24 months
Secondary	Cardiac echocardiography	Composite outcome measure	24 months
Secondary	P-proBNP	Composite outcome measure	24 months