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

R

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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