Renal Denervation in Heart Failure With Preserved Ejection Fraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-09-30

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).

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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.

Conditions

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Cardiac Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal sympathetic denervation

Renal denervation using the Medtronic Symplicity catheter.

Group Type EXPERIMENTAL

Renal sympathetic denervation

Intervention Type DEVICE

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

Control

HF-PEF patients who will serve as control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Renal sympathetic denervation

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

Intervention Type DEVICE

Other Intervention Names

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Medtronic Symplicity Catheter

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No