Renal Denervation in Heart Failure With Preserved Ejection Fraction (RDT-PEF)

Royal Brompton & Harefield NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Cardiac Failure

Treatments: Device: Renal sympathetic denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01840059

2012HS001B

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Renal sympathetic denervation

Experimental group

Description:

Renal denervation using the Medtronic Symplicity catheter.

Treatment:

Device: Renal sympathetic denervation

Control

No Intervention group

Description:

HF-PEF patients who will serve as control.