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

Not Applicable

• Conditions: Hypertension; Heart Failure, Diastolic
• Interventions: Procedure: Renal denervation + medical therapy

• Registration Number: NCT02115230
• Lead Sponsor: InCor Heart Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-13
• Study First Submitted QC: 2014-04-13
• Last Update Submitted: 2014-04-13
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Heart Institute - InCor. University of Sao Paulo Medical School; 🇧🇷 São Paulo, SP, Brazil