Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction

Study Overview
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Brief Summary
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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.

Official Title
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Transcatheter Renal Denervation in Heart Failure With Normal Left Ventricular Ejection Fraction - a Safety and Efficacy Study of Irrigated Radiofrequency Catheter

Conditions
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Heart Failure, Diastolic, Hypertension

Intervention / Treatment
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* Procedure: Renal denervation + medical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation + medical therapy<br>Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure | Procedure: Renal denervation + medical therapy<br>* 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<br>|
| No Intervention: Medical therapy<br>Standard optimized medical therapy for diastolic heart failure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline E/E' on echocardiography at 6 months |  | 6 months | 
| Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months |  | 12 months | 
| 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 in serum B-type natriuretic peptide (BNP) between baseline and 12 months |  | 12 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Heart Failure, Diastolic, Hypertension, Renal Denervation, Irrigated Radiofrequency Catheter