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

March 9, 2021 updated by: Turku University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Vaasa, Finland, 65130
        • Vaasa Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable hemodynamic state
  • uncooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: Renal nervous denervation (delayed)
Renal nervous denervation is performed after six months on the waiting list
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walking test
Time Frame: 24 months
Composite outcome measure
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient history
Time Frame: 24 months
Composite outcome measure
24 months
Cardiac echocardiography
Time Frame: 24 months
Composite outcome measure
24 months
P-proBNP
Time Frame: 24 months
Composite outcome measure
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Satakunta Central Hospital

Investigators

  • Study Chair: Mari-Anne Vaittinen, MD, Vaasa Central Hospitla
  • Study Chair: Mari-Anne Vaittinen, MD, Vaasa Central Hospital, Vaasa, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 23, 2015

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Juhani02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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