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

University of São Paulo (USP)

Status: Unknown

Conditions: Hypertension; Heart Failure, Diastolic

Treatments: Procedure: Renal denervation + medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02115230

IncorRDN-ICFEN

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Renal denervation + medical therapy

Experimental group

Description:

Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure

Treatment:

Procedure: Renal denervation + medical therapy

Medical therapy

No Intervention group

Description:

Standard optimized medical therapy for diastolic heart failure