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

September 14, 2015 updated by: Royal Brompton & Harefield NHS Foundation Trust

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal sympathetic denervation
Renal denervation using the Medtronic Symplicity catheter.
Device: 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
Other Names:
  • Medtronic Symplicity Catheter
No Intervention: Control
HF-PEF patients who will serve as control.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Investigators

  • Principal Investigator: Carlo di Mario, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012HS001B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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