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Renal Artery Denervation in Chronic Heart Failure (REACH-Pilot)

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ClinicalTrials.gov Identifier: NCT01584700
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Congestive Cardiac Failure Procedure: Renal Artery Denervation Phase 1

Detailed Description:

One of the key physiological changes seen in heart failure patients is overactivity of the sympathetic nervous system. This is a homeostatic response produced by the body in an attempt to compensate for a poorly functioning heart and the resultant underperfused tissues. In acute heart failure this has a positive effect but in chronic heart failure, the long standing sympathetic overactivity causes multiple undesirable side effects including profound vasoconstriction, increased sodium reabsorption by the kidneys, renin release and decreased renal blood flow. Afferent and efferent sympathetic chains in the renal artery play an important role in the mediation of this response.

Current management of heart failure principally hinges on drugs that attempt to attenuate or interrupt this response via renin angiotensin system, adrenoreceptors or the renal tubules. These drugs have multiple side effects, partly because of their multiple sites of action. None directly target the sympathetic discharge at its source.

The development of renal artery denervation opens a unique opportunity for potentially longlasting relief of this intense renal sympathetic over-activity. The technique has a current role in the management of resistant hypertension where it has shown very favourable results with minimal side effects. The investigators envisage that this technique could also be highly beneficial to patients with heart failure by directly interrupting this sympathetic overactivity. This initial study involving 7 patients is a pilot safety study to assess this potential.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Artery Denervation in Chronic Heart Failure- Pilot
Study Start Date : January 2011
Primary Completion Date : March 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Renal Artery Denervation
Ontervention
Procedure: Renal Artery Denervation
Radiofrequency ablation of the renal artery sympathetic outflow tract.


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 1 year ]
    To ensure that patients with heart failure are able to acceptably tolerate the procedure and its potential effect on haemodynamics.


Secondary Outcome Measures :
  1. NYHA classification [ Time Frame: 1 year ]
    To assess NYHA classification of dyspnoea

  2. 6 minute walk test [ Time Frame: 1 year ]
    To assess impact on 6 minute walk test

  3. Cardiopulmonary testing [ Time Frame: 1 year ]
    To assess the impact on cardiopulmonary exercise testing

  4. NT-proBNP [ Time Frame: 1 year ]
    To assess the impact on NT-proBNP levels

  5. Urinary excretion of renal hormones [ Time Frame: 1 year ]
    To assess the impact on the urinary excretion of renal hormones


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT01584700


Locations
United Kingdom
Hammersmith Hospital
London, United Kingdom, W120HS
St Mary's Hospital
London, United Kingdom, W21NY
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Justin E Davies, PhD Imperial College London
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01584700     History of Changes
Other Study ID Numbers: JROSM0135
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: July 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: waiting

Keywords provided by Imperial College London:
NYHA class III or IV
Maximal medical therapy
Not eligible for CRT

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases