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

Primary Purpose

Cardiac Failure

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Renal sympathetic denervation
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Failure focused on measuring Cardiac Failure, Autonomic Denervation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal sympathetic denervation

Control

Arm Description

Renal denervation using the Medtronic Symplicity catheter.

HF-PEF patients who will serve as control.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Autonomic function
Heart rate variability
Change in Renal function
Urea and Creatinine
Change in Vascular function
Aorta MRI (Magnetic Resonance Imaging)
Change in Autonomic function
mIBG radiotracer assessment
Change in neurohormones
Neurohormones
Change in renal blood flow
Renal MRI
Change in Blood pressure
ABPM (Ambulatory Blood Pressure Monitoring)
Change in Endothelial function
EndoPat

Full Information

First Posted
April 17, 2013
Last Updated
September 14, 2015
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01840059
Brief Title
Renal Denervation in Heart Failure With Preserved Ejection Fraction
Acronym
RDT-PEF
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure
Keywords
Cardiac Failure, Autonomic Denervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal sympathetic denervation
Arm Type
Experimental
Arm Description
Renal denervation using the Medtronic Symplicity catheter.
Arm Title
Control
Arm Type
No Intervention
Arm Description
HF-PEF patients who will serve as control.
Intervention Type
Device
Intervention Name(s)
Renal sympathetic denervation
Other Intervention Name(s)
Medtronic Symplicity Catheter
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Symptoms
Description
Minnesota Living with Heart Failure Questionnaire
Time Frame
12 months
Title
Change in Exercise Function
Description
Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing
Time Frame
12 months
Title
Change in Heart Failure Biomarker
Description
BNP (Natriuretic peptide)
Time Frame
12 months
Title
Change in LV (Left Ventricle) filling pressure
Description
E/E' on echocardiography
Time Frame
12 months
Title
Change in LV remodelling
Description
LV mass index
Time Frame
12 months
Title
Change in Left atrial (LA) size
Description
LA volume index
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Autonomic function
Description
Heart rate variability
Time Frame
3 and 12 months
Title
Change in Renal function
Description
Urea and Creatinine
Time Frame
3 and 12 months
Title
Change in Vascular function
Description
Aorta MRI (Magnetic Resonance Imaging)
Time Frame
3 and 12 months
Title
Change in Autonomic function
Description
mIBG radiotracer assessment
Time Frame
3 and 12 months
Title
Change in neurohormones
Description
Neurohormones
Time Frame
3 and 12 months
Title
Change in renal blood flow
Description
Renal MRI
Time Frame
3 and 12 months
Title
Change in Blood pressure
Description
ABPM (Ambulatory Blood Pressure Monitoring)
Time Frame
3 and 12 months
Title
Change in Endothelial function
Description
EndoPat
Time Frame
3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo di Mario
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22392370
Citation
Sobotka PA, Krum H, Bohm M, Francis DP, Schlaich MP. The role of renal denervation in the treatment of heart failure. Curr Cardiol Rep. 2012 Jun;14(3):285-92. doi: 10.1007/s11886-012-0258-x.
Results Reference
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Renal Denervation in Heart Failure With Preserved Ejection Fraction

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