Renal Denervation in Heart Failure With Preserved Ejection Fraction

Royal Brompton & Harefield NHS Foundation Trust25 enrolled

Overview

The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF).

Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in heart failure with preserved left ventricular ejection fraction. The current study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the SNS in patients with HF-PEF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Failure

Interventions

Renal sympathetic denervationDEVICE

A fit for purpose radiofrequency catheter is guided to the renal artery using fluoroscopy. This is connected to an external RF generator. RF energy is applied through the catheter to the renal artery wall with the goal of disrupting the sympathetic nerves which run in the adventitia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * EF\>40% * NHYA 2-3 * Evidence of HF-PEF (mixture of dilated left atrium, left ventricular hypertrophy, raised E/E', elevated LVEDP/PCWP, raised BNP) Exclusion Criteria: * Previously documented EF\<40% * Hypertrophic, restrictive, dilated cardiomyopathy * Significant valvular heart disease * Unfavourable renal artery anatomy for renal denervation * eGFR\<45 * Contraindication to MRI * Myocardial infarction, unstable angina or cerebrovascular accident in last 3 months

Locations (1)

Royal Brompton Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Change in Symptoms

Minnesota Living with Heart Failure Questionnaire

Time frame: 12 months

Change in Exercise Function

Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing

Time frame: 12 months

Change in Heart Failure Biomarker

BNP (Natriuretic peptide)

Time frame: 12 months

Change in LV (Left Ventricle) filling pressure

E/E' on echocardiography

Time frame: 12 months

Change in LV remodelling

LV mass index

Time frame: 12 months

Change in Left atrial (LA) size

LA volume index

Time frame: 12 months

Secondary Outcomes

Change in Autonomic function

Heart rate variability

Time frame: 3 and 12 months

Change in Renal function

Urea and Creatinine

Time frame: 3 and 12 months

Change in Vascular function

Aorta MRI (Magnetic Resonance Imaging)

Time frame: 3 and 12 months

Change in Autonomic function

Data from ClinicalTrials.gov

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