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

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

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 Overview

• Status: Unknown
• Conditions: Hypertension; Heart Failure, Diastolic
• Intervention / Treatment: Procedure: Renal denervation + medical therapy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-000
      • Recruiting
      • Heart Institute - InCor. University of Sao Paulo Medical School
      • Contact: Patricia Pereira; Phone Number: +55 11 2661-5368; Email: patricia.pereira@incor.usp.br
      • Principal Investigator: Pedro Lemos, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
No Intervention: Medical therapy; Standard optimized medical therapy for diastolic heart failure

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: InCor Heart Institute
• Investigators: Study Chair: Pedro A Lemos, MD PhD, Heart Institute - InCor. University of Sao Paulo Medical School

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: April 13, 2014
• First Submitted That Met QC Criteria: April 13, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 13, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Heart Failure; Hypertension; Heart Failure, Diastolic; Renal Denervation; Irrigated Radiofrequency Catheter
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Hypertension; Heart Failure, Diastolic
• Other Study ID Numbers: IncorRDN-ICFEN