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Completed

NCT Number: NCT01840059

Renal Denervation in 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).

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Key information

Conditions

Cardiac Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Sympathetic Denervation

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

Other names: Medtronic Symplicity Catheter

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study 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.

Acronym: RDT-PEF

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2013
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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