Renal Denervation in Heart Failure With Preserved Ejection Fraction

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomised Controlled Trial Investigating the Effect of Transcatheter Renal Sympathetic Denervation on Symptoms and Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction.

Conditions
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Cardiac Failure

Intervention / Treatment
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* Device: Renal sympathetic denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal sympathetic denervation<br>Renal denervation using the Medtronic Symplicity catheter. | Device: Renal sympathetic denervation<br>* 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<br>* Other names: Medtronic Symplicity Catheter;|
| No Intervention: Control<br>HF-PEF patients who will serve as control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symptoms | Minnesota Living with Heart Failure Questionnaire | 12 months | 
| Change in Exercise Function | Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing | 12 months | 
| Change in Heart Failure Biomarker | BNP (Natriuretic peptide) | 12 months | 
| Change in LV (Left Ventricle) filling pressure | E/E' on echocardiography | 12 months | 
| Change in LV remodelling | LV mass index | 12 months | 
| Change in Left atrial (LA) size | LA volume index | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Autonomic function | Heart rate variability | 3 and 12 months | 
| Change in Renal function | Urea and Creatinine | 3 and 12 months | 
| Change in Vascular function | Aorta MRI (Magnetic Resonance Imaging) | 3 and 12 months | 
| Change in Autonomic function | mIBG radiotracer assessment | 3 and 12 months | 
| Change in neurohormones | Neurohormones | 3 and 12 months | 
| Change in renal blood flow | Renal MRI | 3 and 12 months | 
| Change in Blood pressure | ABPM (Ambulatory Blood Pressure Monitoring) | 3 and 12 months | 
| Change in Endothelial function | EndoPat | 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Failure, Autonomic Denervation