NCT01584700

Brief Summary

Heart failure is a common condition with debilitating symptoms and a poor prognosis. Patients with heart failure have a massively overactive sympathetic nervous system which attempts to compensate for their poorly functioning heart. This ultimately has only detrimental effects. One of the principle mediators for this sympathetic response is found in the nerve cells in the kidneys. Whilst a significant proportion of medications used to treat heart failure act on these harmful pathways, none target the kidney sympathetic-nerve cells specifically. Additionally, because of their multiple sites of action these drugs all have side effects. A new procedure that has recently been developed for the treatment of high blood pressure is renal denervation. This involves inserting a small catheter through the femoral artery and passing it to the kidney artery under x-ray guidance. From there, using radiofrequency waves, the sympathetic nerves within the kidney can be destroyed. The investigators anticipate that this procedure will have a significant positive effect on patients with heart failure and aim to perform a pilot safety study on 7 individuals with advanced heart failure to assess its safety and effectiveness. The investigators hypothesise that renal artery denervation will lead to significant clinical and biochemical improvements in patients with marked heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

2 active sites

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

January 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 23, 2016

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

September 29, 2011

Last Update Submit

August 22, 2016

Conditions

Congestive Cardiac Failure

Keywords

NYHA class III or IVMaximal medical therapyNot eligible for CRT

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events

    To ensure that patients with heart failure are able to acceptably tolerate the procedure and its potential effect on haemodynamics.

    1 year

Secondary Outcomes (5)

  • NYHA classification

    1 year

  • 6 minute walk test

    1 year

  • Cardiopulmonary testing

    1 year

  • NT-proBNP

    1 year

  • Urinary excretion of renal hormones

    1 year

Study Arms (1)

Renal Artery Denervation

OTHER

Ontervention

Procedure: Renal Artery Denervation

Interventions

Renal Artery DenervationPROCEDURE

Radiofrequency ablation of the renal artery sympathetic outflow tract.

Renal Artery Denervation

Eligibility Criteria

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

You may qualify if:

  • congestive cardiac failure
  • maximal medical therapy
  • NYHA class III/IV

You may not qualify if:

  • clinically unstable
  • pre-existing renal disease
  • unfavourable anatomy
  • tortuous femoral anatomy
  • unable to consent
  • CRT present or eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hammersmith Hospital

London, W120HS, United Kingdom

Location

St Mary's Hospital

London, W21NY, United Kingdom

Location

Related Publications (2)

  • Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.

    PMID: 19332353BACKGROUND

  • Davies JE, Manisty CH, Petraco R, Barron AJ, Unsworth B, Mayet J, Hamady M, Hughes AD, Sever PS, Sobotka PA, Francis DP. First-in-man safety evaluation of renal denervation for chronic systolic heart failure: primary outcome from REACH-Pilot study. Int J Cardiol. 2013 Jan 20;162(3):189-92. doi: 10.1016/j.ijcard.2012.09.019. Epub 2012 Sep 29.

    PMID: 23031283DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Justin E Davies, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

April 25, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

August 23, 2016

Record last verified: 2012-07

Locations

GB(2)