Renal Artery Denervation in Chronic Heart Failure

Congestive Cardiac Failure Clinical Trial

— REACH-Pilot  

Official title:

Renal Artery Denervation in Chronic Heart Failure- Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584700
• Other study ID #: JROSM0135
• Status: Completed
• Phase: Phase 1
• First received: September 29, 2011
• Last updated: August 22, 2016
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Cardiac Failure
• Heart Failure

Intervention

Procedure:
• Renal Artery Denervation
Radiofrequency ablation of the renal artery sympathetic outflow tract.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London
United Kingdom	St Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	NYHA classification	To assess NYHA classification of dyspnoea	1 year	No
Secondary	6 minute walk test	To assess impact on 6 minute walk test	1 year	No
Secondary	Cardiopulmonary testing	To assess the impact on cardiopulmonary exercise testing	1 year	No
Secondary	NT-proBNP	To assess the impact on NT-proBNP levels	1 year	No
Secondary	Urinary excretion of renal hormones	To assess the impact on the urinary excretion of renal hormones	1 year	No