Back to resultsRenal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction
Primary Purpose
Heart Failure, Diastolic, Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Renal denervation + medical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Diastolic focused on measuring Heart Failure, Heart Failure, Diastolic, Hypertension, Renal Denervation, Irrigated Radiofrequency Catheter
Eligibility Criteria
Inclusion Criteria:
- Hypertension treated with at least 2 antihypertensive drugs;
- Heart failure with a normal LV ejection fraction;
- Left Ventricular Hypertrophy (LV mass index > 96 g/m2 in women and > 116 g/m2 in men);
- ≥ 18 years of age;
Exclusion Criteria:
- Known secondary cause of hypertension
- Uncontrolled blood pressure (≥ 180x110mmHg)
- Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
- Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters)
- Diabetes Mellitus type 1
- Acute coronary syndrome or a cerebrovascular accident in the last 6 months
- Known other cause of respiratory dysfunction
- Previous LV systolic dysfunction (LVEF < 50%)
- Restrictive cardiomyopathy or Hypertrophic cardiomyopathy
- Significant valvar dysfunction
- Atrial flutter or atrial fibrillation
- Use of the oral anticoagulants
- Drug and Alcohol dependence
Sites / Locations
- Heart Institute - InCor. University of Sao Paulo Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Renal denervation + medical therapy
Medical therapy
Arm Description
Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure
Standard optimized medical therapy for diastolic heart failure
Outcomes
Primary Outcome Measures
Efficacy: Change from baseline E/E' on echocardiography at 12 months
Safety: Composite of death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline)
Secondary Outcome Measures
Change from baseline E/E' on echocardiography at 6 months
Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months
Change in any echocardiographic diastolic parameter between baseline and 12 months
Change in 6 min walking distance between baseline and 12 months
Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months
Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months
Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months
Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months
Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02115230
Brief Title
Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction
Official Title
Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is a randomized prospective controlled study of transcatheter renal denervation in patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic, Hypertension
Keywords
Heart Failure, Heart Failure, Diastolic, Hypertension, Renal Denervation, Irrigated Radiofrequency Catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renal denervation + medical therapy
Arm Type
Experimental
Arm Description
Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure
Arm Title
Medical therapy
Arm Type
No Intervention
Arm Description
Standard optimized medical therapy for diastolic heart failure
Intervention Type
Procedure
Intervention Name(s)
Renal denervation + medical therapy
Intervention Description
Renal denervation + medical therapy Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure
Primary Outcome Measure Information:
Title
Efficacy: Change from baseline E/E' on echocardiography at 12 months
Time Frame
12 months after treatment
Title
Safety: Composite of death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline E/E' on echocardiography at 6 months
Time Frame
6 months
Title
Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months
Time Frame
12 months
Title
Change in any echocardiographic diastolic parameter between baseline and 12 months
Time Frame
12 months
Title
Change in 6 min walking distance between baseline and 12 months
Time Frame
12 months
Title
Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months
Time Frame
12 months
Title
Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months
Time Frame
12 months
Title
Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months
Time Frame
12 months
Title
Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months
Time Frame
12 months
Title
Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertension treated with at least 2 antihypertensive drugs;
Heart failure with a normal LV ejection fraction;
Left Ventricular Hypertrophy (LV mass index > 96 g/m2 in women and > 116 g/m2 in men);
≥ 18 years of age;
Exclusion Criteria:
Known secondary cause of hypertension
Uncontrolled blood pressure (≥ 180x110mmHg)
Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters)
Diabetes Mellitus type 1
Acute coronary syndrome or a cerebrovascular accident in the last 6 months
Known other cause of respiratory dysfunction
Previous LV systolic dysfunction (LVEF < 50%)
Restrictive cardiomyopathy or Hypertrophic cardiomyopathy
Significant valvar dysfunction
Atrial flutter or atrial fibrillation
Use of the oral anticoagulants
Drug and Alcohol dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro A Lemos, MD PhD
Organizational Affiliation
Heart Institute - InCor. University of Sao Paulo Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Institute - InCor. University of Sao Paulo Medical School
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Pereira
Phone
+55 11 2661-5368
Email
patricia.pereira@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Pedro Lemos, MD PhD
12. IPD Sharing Statement
Learn more about this trial
Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction
We'll reach out to this number within 24 hrs