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

InCor Heart Institute40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure, Diastolic Hypertension

Interventions

Renal denervation + medical therapyPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Efficacy: Change from baseline E/E' on echocardiography at 12 months

Time frame: 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)

Time frame: 12 months

Secondary Outcomes

Change from baseline E/E' on echocardiography at 6 months

Time frame: 6 months

Change of office blood pressure and ambulatory blood pressure monitoring (ABPM) between baseline and 12 months

Time frame: 12 months

Change in any echocardiographic diastolic parameter between baseline and 12 months

Time frame: 12 months

Change in 6 min walking distance between baseline and 12 months

Time frame: 12 months

Change in quality of life (Minnesota Living with Heart Failure Questionnaire) between baseline and 12 months

Time frame: 12 months

Change in serum B-type natriuretic peptide (BNP) between baseline and 12 months

Time frame: 12 months

Change in peripheral sympathetic activity measured by microneurography between baseline and 12 months

Time frame: 12 months

Change in non-invasive hemodynamic parameters provided by Finometer between baseline and 12 months

Data from ClinicalTrials.gov

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