Renal Denervation in Heart Failure With Preserved Ejection Fraction

Phase 2

Completed

• Conditions: Cardiac Failure
• Interventions: Device: Renal sympathetic denervation

• Registration Number: NCT01840059
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

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

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal sympathetic denervation	Renal sympathetic denervation	Renal denervation using the Medtronic Symplicity catheter.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Blood pressure	3 and 12 months	ABPM (Ambulatory Blood Pressure Monitoring)
Change in Renal function	3 and 12 months	Urea and Creatinine
Change in neurohormones	3 and 12 months	Neurohormones
Change in Autonomic function	3 and 12 months	mIBG radiotracer assessment
Change in Vascular function	3 and 12 months	Aorta MRI (Magnetic Resonance Imaging)
Change in renal blood flow	3 and 12 months	Renal MRI
Change in Endothelial function	3 and 12 months	EndoPat

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom