Congestive Cardiac FailurePhase 1REACH-PilotNCT01584700
Renal Artery Denervation in Chronic Heart Failure
A Phase 1 study testing Renal Artery Denervation in people with Congestive Cardiac Failure, run by Imperial College London at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Cardiac Failure
- What is being tested?
- Renal Artery Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- congestive cardiac failure
- maximal medical therapy
- NYHA class III/IV
Who cannot join
- clinically unstable
- pre-existing renal disease
- unfavourable anatomy
- tortuous femoral anatomy
- unable to consent
- CRT present or eligible
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hammersmith Hospital
London, W120HS
St Mary's Hospital
London, W21NY
About this study
Official title: Renal Artery Denervation in Chronic Heart Failure- Pilot
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.
Read more
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.
Read the 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.
- Conditions
- Congestive Cardiac Failure
- Being tested
- Renal Artery Denervation
- Keywords
- NYHA class III or IV, Maximal medical therapy, Not eligible for CRT
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Artery DenervationProcedure or surgery
Radiofrequency ablation of the renal artery sympathetic outflow tract.
| Study group | Role | What they receive |
|---|---|---|
| Renal Artery Denervation | Other | Ontervention Receives: Procedure: Renal Artery Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
NYHA classification
To assess NYHA classification of dyspnoea
Measured: 1 year
6 minute walk test
To assess impact on 6 minute walk test
Measured: 1 year
Cardiopulmonary testing
To assess the impact on cardiopulmonary exercise testing
Measured: 1 year
NT-proBNP
To assess the impact on NT-proBNP levels
Measured: 1 year
Urinary excretion of renal hormones
To assess the impact on the urinary excretion of renal hormones
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congestive Cardiac FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin E Davies, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584700
- Sponsor's protocol ID
- JROSM0135
- Acronym
- REACH-Pilot
- Status last verified
- Jul 2012
- First submitted
- 29 Sep 2011
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: waiting
Publications
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.
PubMed 19332353Davies 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.
PubMed 23031283
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Artery Denervation in Chronic Heart Failure- Pilot
- ClinicalTrials.gov ID
- NCT01584700
- Acronym / sponsor ID
- REACH-Pilot / JROSM0135
- Conditions
- Congestive Cardiac Failure
- Keywords
- NYHA class III or IV, Maximal medical therapy, Not eligible for CRT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Artery Denervation | Other | Procedure: Renal Artery DenervationOntervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- congestive cardiac failure
- maximal medical therapy
- NYHA class III/IV
Key exclusion criteria (6 listed)
- clinically unstable
- pre-existing renal disease
- unfavourable anatomy
- tortuous femoral anatomy
- unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Artery DenervationRadiofrequency ablation of the renal artery sympathetic outflow tract. | Procedure or surgery | Renal Artery Denervation |
Primary outcome
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.
5 secondary outcomes
NYHA classification
Time frame: 1 year
6 minute walk test
Time frame: 1 year
Cardiopulmonary testing
Time frame: 1 year
NT-proBNP
Time frame: 1 year
Urinary excretion of renal hormones
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Background: PubMed 19332353Krum 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.
- Derived from this study: PubMed 23031283Davies 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.
- Individual participant dataSharing planned: Undecided. waiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin E Davies, PhD principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Renal Artery Denervation in people with Congestive Cardiac Failure, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01584700, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.