Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction
NCT ID: NCT02115230
Last Updated: 2014-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Renal denervation + medical therapy
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
Medical therapy
Standard optimized medical therapy for diastolic heart failure
No interventions assigned to this group
Interventions
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Renal denervation + medical therapy
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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InCor Heart Institute
OTHER
Responsible Party
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Pedro A. Lemos
Pedro A. Lemos, Professor of Medicine, InCor Heart Institute
Principal Investigators
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Pedro A Lemos, MD PhD
Role: STUDY_CHAIR
Heart Institute - InCor. University of Sao Paulo Medical School
Locations
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Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, São Paulo, Brazil
Countries
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Facility Contacts
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Other Identifiers
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IncorRDN-ICFEN
Identifier Type: -
Identifier Source: org_study_id
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