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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840059
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

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).

Condition or disease Intervention/treatment Phase
Cardiac Failure Device: Renal sympathetic denervation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: Medtronic Symplicity Catheter

No Intervention: Control
HF-PEF patients who will serve as control.



Primary Outcome Measures :
  1. Change in Symptoms [ Time Frame: 12 months ]
    Minnesota Living with Heart Failure Questionnaire

  2. Change in Exercise Function [ Time Frame: 12 months ]
    Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing

  3. Change in Heart Failure Biomarker [ Time Frame: 12 months ]
    BNP (Natriuretic peptide)

  4. Change in LV (Left Ventricle) filling pressure [ Time Frame: 12 months ]
    E/E' on echocardiography

  5. Change in LV remodelling [ Time Frame: 12 months ]
    LV mass index

  6. Change in Left atrial (LA) size [ Time Frame: 12 months ]
    LA volume index


Secondary Outcome Measures :
  1. Change in Autonomic function [ Time Frame: 3 and 12 months ]
    Heart rate variability

  2. Change in Renal function [ Time Frame: 3 and 12 months ]
    Urea and Creatinine

  3. Change in Vascular function [ Time Frame: 3 and 12 months ]
    Aorta MRI (Magnetic Resonance Imaging)

  4. Change in Autonomic function [ Time Frame: 3 and 12 months ]
    mIBG radiotracer assessment

  5. Change in neurohormones [ Time Frame: 3 and 12 months ]
    Neurohormones

  6. Change in renal blood flow [ Time Frame: 3 and 12 months ]
    Renal MRI

  7. Change in Blood pressure [ Time Frame: 3 and 12 months ]
    ABPM (Ambulatory Blood Pressure Monitoring)

  8. Change in Endothelial function [ Time Frame: 3 and 12 months ]
    EndoPat



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840059


Locations
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United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Carlo di Mario Royal Brompton & Harefield NHS Foundation Trust

Publications:
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01840059    
Other Study ID Numbers: 2012HS001B
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Cardiac Failure
Autonomic Denervation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases