Heart Failure, Diastolic, Hypertension
Conditions
Keywords
Heart Failure, Heart Failure, Diastolic, Hypertension, Renal Denervation, Irrigated Radiofrequency Catheter
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.
Interventions
PROCEDURERenal 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
Sponsors
InCor Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Change from baseline E/E' on echocardiography at 12 months | 12 months after treatment |
| 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) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in any echocardiographic diastolic parameter between baseline and 12 months | 12 months |
| Change in 6 min walking distance between baseline and 12 months | 12 months |
| Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months | 12 months |
| Change from baseline E/E' on echocardiography at 6 months | 6 months |
| Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months | 12 months |
| Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months | 12 months |
| Change in renal function (GFR, albuminury and 24h urinary Na excretion) between baseline and 12 months | 12 months |
| Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months | 12 months |
| Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months | 12 months |
Countries
Brazil
Outcome results
None listed