Supportive Treatment of Severe Heart Failure by Renal Denervation (Heart-RND)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Renal nervous denervation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Renal nervous denervation
Eligibility Criteria
Inclusion Criteria:
- NYHA III-IV
- ejection fraction <45 %
- 6-minute walking test under 440m
Exclusion Criteria:
- Unstable hemodynamic state
- uncooperation
Sites / Locations
- Vaasa Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Renal nervous denervation.
Renal nervous denervation (delayed)
Arm 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.
Renal nervous denervation is performed after six months on the waiting list
Outcomes
Primary Outcome Measures
6-minute walking test
Composite outcome measure
Secondary Outcome Measures
Patient history
Composite outcome measure
Cardiac echocardiography
Composite outcome measure
P-proBNP
Composite outcome measure
Full Information
NCT ID
NCT02638324
First Posted
May 20, 2015
Last Updated
March 9, 2021
Sponsor
Turku University Hospital
Collaborators
Satakunta Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02638324
Brief Title
Supportive Treatment of Severe Heart Failure by Renal Denervation
Acronym
Heart-RND
Official Title
Supportive Treatment of Severe Heart Failure by Renal Denervation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Because of the lack of the candidates and because of restrictions of denervation at the completion date.
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
Satakunta Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Renal nervous denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal nervous denervation.
Arm Type
Active Comparator
Arm 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.
Arm Title
Renal nervous denervation (delayed)
Arm Type
Active Comparator
Arm Description
Renal nervous denervation is performed after six months on the waiting list
Intervention Type
Procedure
Intervention Name(s)
Renal nervous denervation
Intervention Description
The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.
Primary Outcome Measure Information:
Title
6-minute walking test
Description
Composite outcome measure
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient history
Description
Composite outcome measure
Time Frame
24 months
Title
Cardiac echocardiography
Description
Composite outcome measure
Time Frame
24 months
Title
P-proBNP
Description
Composite outcome measure
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
NYHA III-IV
ejection fraction <45 %
6-minute walking test under 440m
Exclusion Criteria:
Unstable hemodynamic state
uncooperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mari-Anne Vaittinen, MD
Organizational Affiliation
Vaasa Central Hospitla
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mari-Anne Vaittinen, MD
Organizational Affiliation
Vaasa Central Hospital, Vaasa, Finland
Official's Role
Study Chair
Facility Information:
Facility Name
Vaasa Central Hospital
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Supportive Treatment of Severe Heart Failure by Renal Denervation
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