Chronic Systolic Heart FailurePhase 3REACHNCT01639378
Renal Artery Denervation in Chronic Heart Failure Study
A Phase 3 study testing Renal Denervation in people with Chronic Systolic Heart Failure, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Systolic Heart Failure
- What is being tested?
- Renal Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Apr 2017
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure due to systolic dysfunction
- New York Heart Association class II or higher
- Maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ACE inhibitors /A2 blocker, Aldosterone blockade.
- Ejection fraction less than 40%
Who cannot join
- Estimated GFR<35ml/hr
- Unfavourable renal anatomy (renal artery stenosis)
- Unable to walk on a treadmill for cardiopulmonary exercise test
- Significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation)
- Severe lung disease
- Symptomatic orthostatic dizziness
- Unable to consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.
Read the detailed description
Interventional study
Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation.
Primary Purpose: Treatment
Chronic Systolic Heart Failure
Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System
-Intervention: Device: Renal denervation (Symplicity Catheter System)
Patients are randomised in the cath lab to receive either renal denervation or sham procedure.
Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure)
In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.
- Conditions
- Chronic Systolic Heart Failure
- Being tested
- Renal Denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationProcedure or surgery
Symplicity Catheter System
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Subjects are treated with renal denervation after randomisation and maintained on heart failure medications Receives: Procedure: Renal Denervation |
| Control group | No intervention | Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptomatology
Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
Measured: Baseline to 12 months post-randomization
Secondary outcomes (5)
Improvement in peak VO2 on cardiopulmonary exercise testing
The peak VO2 will be compared in the interventional against the sham arm
Measured: Baseline to 12 months post-randomization
Improvement in self-paced exercise distance
Improvement in 6 min walk to in interventional arm compared to sham arm
Measured: Baseline to 12 months post-randomization
Change in chemoreflex sensitivity
Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm
Measured: Baseline to 12 months post-randomization
Change in NYHA functional classification
Assess the change in NYHA in interventional arm in comparison to sham arm
Measured: Baseline to 12 months post-randomization
Incidence of Major Adverse Events
The incidence of major adverse events will be compared in the interventional against the sham arm
Measured: Baseline to 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Systolic Heart 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darrel P Francis, BA, MD, Study director, Imperial College LondonJustin E Davies, MBBS, PHD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639378
- Sponsor's protocol ID
- REACH
- Acronym
- REACH
- Status last verified
- Aug 2016
- First submitted
- 10 Jul 2012
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22392370
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
- ClinicalTrials.gov ID
- NCT01639378
- Acronym / sponsor ID
- REACH / REACH
- Conditions
- Chronic Systolic Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2017 (estimated)
- First posted
- 12 Jul 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.
The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.
Detailed description
Interventional study
Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation.
Primary Purpose: Treatment
Chronic Systolic Heart Failure
Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System
-Intervention: Device: Renal denervation (Symplicity Catheter System)
Patients are randomised in the cath lab to receive either renal denervation or sham procedure.
Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure)
In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Procedure: Renal DenervationSubjects are treated with renal denervation after randomisation and maintained on heart failure medications |
| Control group | No intervention | –Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic heart failure due to systolic dysfunction
- New York Heart Association class II or higher
- Maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ACE inhibitors /A2 blocker, Aldosterone blockade.
- Ejection fraction less than 40%
Key exclusion criteria (8 listed)
- Estimated GFR<35ml/hr
- Unfavourable renal anatomy (renal artery stenosis)
- Unable to walk on a treadmill for cardiopulmonary exercise test
- Significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation)
- Severe lung disease
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 DenervationSymplicity Catheter System | Procedure or surgery | Renal Denervation |
Primary outcome
Improvement in symptomatology
Time frame: Baseline to 12 months post-randomization
Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
5 secondary outcomes
Improvement in peak VO2 on cardiopulmonary exercise testing
Time frame: Baseline to 12 months post-randomization
Improvement in self-paced exercise distance
Time frame: Baseline to 12 months post-randomization
Change in chemoreflex sensitivity
Time frame: Baseline to 12 months post-randomization
Change in NYHA functional classification
Time frame: Baseline to 12 months post-randomization
Incidence of Major Adverse Events
Time frame: Baseline to 12 months post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Background: PubMed 22392370Sobotka 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.
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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.
Darrel P Francis, BA, MD study director
Imperial College London
Justin E Davies, MBBS, PHD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renal Denervation in people with Chronic Systolic Heart Failure, run by Imperial College London at 1 site 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Improvement in symptomatology (time frame: Baseline to 12 months post-randomization). 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 NCT01639378, which also lists 1 linked publication.
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 11 Nov 2016.