Heart FailurePhase 1REACHNCT02146794
Renal Denervation in Chronic Heart Failure
A Phase 1 study testing Renal denervation in people with Heart Failure, run by Imperial College London.
Trial summary
Renal denervation can be carried out for heart failure Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone.
Who cannot join
- Clinically unstable patients or those with significant valvular disease
- An estimated glomerular filtration rate <35 ml/min
- Unfavourable renal anatomy
- Tortuous femoral arteries were not eligible
About this study
Renal denervation can be carried out for heart failure
Read the detailed description
There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety.
This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.
- Conditions
- Heart Failure
- Being tested
- Renal denervation
- 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 denervationDevice
Also called Symplicity Renal Denervation System
Renal denervation
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | renal denervation Receives: Device: Renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Renal denervation had been reported to cause a 30 mmHg fall in blood pressure when used in hypertension. Although in principle renal denervation might be favourable for physiology in chronic heart failure, numerous theoretical possibilities exist for the procedure causing deterioration in clinical status, including the possibility of a large fall in blood pressure.
A deterioration in symptomatic status or occurrence of an event such as presyncope or syncope would be considered a primary outcome event.
Measured: 6 months
Secondary outcomes (5)
Systolic blood pressure
Monitored as inpatient for 5 days, then as outpatient for 6 months
Measured: 6 months
Serum Creatinine
Measured: 6 months
Serum sodium
Measured: 6 months
Serum potassium
Measured: 6 months
6 minute walk distance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 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
- Darrel P Francis, MD, Study chair, Imperial College LondonJustin E Davies, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146794
- Sponsor's protocol ID
- ICCH-10/065
- Acronym
- REACH
- Status last verified
- May 2014
- First submitted
- 19 May 2014
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shun-Shin MJ, Howard JP, Francis DP. Removing the hype from hypertension. BMJ. 2014 Mar 6;348:g1937. doi: 10.1136/bmj.g1937. No abstract available.
PubMed 24603957Howard JP, Cole GD, Sievert H, Bhatt DL, Papademetriou V, Kandzari DE, Davies JE, Francis DP. Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions. Int J Cardiol. 2014 Mar 1;172(1):29-35. doi: 10.1016/j.ijcard.2013.12.183. Epub 2014 Jan 8.
PubMed 24480181Davies 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 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02146794
- Acronym / sponsor ID
- REACH / ICCH-10/065
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 May 2014 (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.
Renal denervation can be carried out for heart failure
Detailed description
There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety.
This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: Renal denervationrenal denervation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone.
Key exclusion criteria (4 listed)
- Clinically unstable patients or those with significant valvular disease
- An estimated glomerular filtration rate <35 ml/min
- Unfavourable renal anatomy
- Tortuous femoral arteries were not eligible
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 denervationAlso: Symplicity Renal Denervation SystemRenal denervation | Device | Renal denervation |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 months
Renal denervation had been reported to cause a 30 mmHg fall in blood pressure when used in hypertension. Although in principle renal denervation might be favourable for physiology in chronic heart failure, numerous theoretical possibilities exist for the procedure causing deterioration in clinical status, including the possibility of a large fall in blood pressure. A deterioration in symptomatic status or occurrence of an event such as presyncope or syncope would be considered a primary outcome event.
5 secondary outcomes
Systolic blood pressure
Time frame: 6 months
Serum Creatinine
Time frame: 6 months
Serum sodium
Time frame: 6 months
Serum potassium
Time frame: 6 months
6 minute walk distance
Time frame: 6 months
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 26 May 2014.
- Background: PubMed 24603957Shun-Shin MJ, Howard JP, Francis DP. Removing the hype from hypertension. BMJ. 2014 Mar 6;348:g1937. doi: 10.1136/bmj.g1937. No abstract available.
- Background: PubMed 24480181Howard JP, Cole GD, Sievert H, Bhatt DL, Papademetriou V, Kandzari DE, Davies JE, Francis DP. Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions. Int J Cardiol. 2014 Mar 1;172(1):29-35. doi: 10.1016/j.ijcard.2013.12.183. Epub 2014 Jan 8.
- Results publication: 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.
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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, MD study chair
Imperial College London
Justin E Davies, MD principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Renal denervation in people with Heart Failure, run by Imperial College London.
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 1 inclusion and 4 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 as a Measure of Safety and Tolerability (time frame: 6 months). 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 NCT02146794, which also lists 3 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 26 May 2014.