Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
renal denervation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring renal denervation
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 year
- heart failure patients NYHA Class II - IV
- implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
- symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
- left ventricular ejection function ≤ 35%
- glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
- patient informed consent for participation in the study
Exclusion Criteria:
- renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
- history of prior renal artery intervention
- single functioning kidney
- clinic systolic BP < 110mmHg
- pregnancy
- acute coronary syndrome or cerebrovascular event within last 3 months
- serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)
Sites / Locations
- Ist Department of Cardiology, Interventional Electrocardiology and HypertensionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active treatment
Observational
Arm Description
Renal denervation
Outcomes
Primary Outcome Measures
Number of hospitalizations due to heart failure worsening.
Change in NYHA class.
Change in 6 minute walk test distance.
Secondary Outcome Measures
Full Information
NCT ID
NCT02329145
First Posted
December 23, 2014
Last Updated
December 29, 2014
Sponsor
Jagiellonian University
1. Study Identification
Unique Protocol Identification Number
NCT02329145
Brief Title
Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
Official Title
Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic heart failure is becoming more and more common disease and activation of sympathetic nervous system plays a crucial role in its development. There is some data allowing to suspect that one of the new treatment methods- renal denervation, also in patients with chronic heart failure may lead to decrease of systemic activity sympathetic nervous system and, as a consequence, to decrease of disease progression. The research hypothesis is whether renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is used (including resynchronization therapy), is contributing to the improvement in parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far only very limited data- mostly case reports- are available in this study area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
renal denervation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Experimental
Arm Description
Renal denervation
Arm Title
Observational
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
renal denervation
Primary Outcome Measure Information:
Title
Number of hospitalizations due to heart failure worsening.
Time Frame
one year
Title
Change in NYHA class.
Time Frame
one year
Title
Change in 6 minute walk test distance.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 year
heart failure patients NYHA Class II - IV
implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
left ventricular ejection function ≤ 35%
glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
patient informed consent for participation in the study
Exclusion Criteria:
renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
history of prior renal artery intervention
single functioning kidney
clinic systolic BP < 110mmHg
pregnancy
acute coronary syndrome or cerebrovascular event within last 3 months
serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksander Kusiak, PhD,MD
Phone
+48124247300
Email
alek.kusiak@gmail.com
Facility Information:
Facility Name
Ist Department of Cardiology, Interventional Electrocardiology and Hypertension
City
Krakow
State/Province
Malopolska
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksander Kusiak, MD, PHD
Phone
+48124247300
Email
alek.kusiak@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
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