NCT01840059

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

April 17, 2013

Last Update Submit

September 14, 2015

Conditions

Cardiac Failure

Keywords

Cardiac FailureAutonomic Denervation

Outcome Measures

Primary Outcomes (6)

  • Change in Symptoms

    Minnesota Living with Heart Failure Questionnaire

    12 months

  • Change in Exercise Function

    Peak VO2 (Oxygen Uptake) on cardiopulmonary exercise testing

    12 months

  • Change in Heart Failure Biomarker

    BNP (Natriuretic peptide)

    12 months

  • Change in LV (Left Ventricle) filling pressure

    E/E' on echocardiography

    12 months

  • Change in LV remodelling

    LV mass index

    12 months

  • Change in Left atrial (LA) size

    LA volume index

    12 months

Secondary Outcomes (8)

  • Change in Autonomic function

    3 and 12 months

  • Change in Renal function

    3 and 12 months

  • Change in Vascular function

    3 and 12 months

  • Change in Autonomic function

    3 and 12 months

  • Change in neurohormones

    3 and 12 months

  • +3 more secondary outcomes

Study Arms (2)

Renal sympathetic denervation

EXPERIMENTAL

Renal denervation using the Medtronic Symplicity catheter.

Device: Renal sympathetic denervation

Control

NO INTERVENTION

HF-PEF patients who will serve as control.

Interventions

Renal sympathetic denervationDEVICE

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

Also known as: Medtronic Symplicity Catheter
Renal sympathetic denervation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22392370BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carlo di Mario

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 25, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

GB(1)