Chronic Heart FailurePhase 1/2DENRENICNCT02471729
Effect at 6 Months of Renal Denervation in Chronic Heart Failure d'Insuffisance Cardiaque
A Phase 1/2 study testing EnligHTN™ Renal Denervation System in people with Chronic Heart Failure, run by Institute Arnault Tzanck, France at 1 site in France.
Trial summary
Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- EnligHTN™ Renal Denervation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jan 2018
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable chronic heart failure
- NYHA III-IV
- LV EF <35 assessed by ultrasound
- EGFR> 45ml / min / 1.73m2
- Optimal therapeutic treatment
- IMC : 17-24
Who cannot join
- significant renovascular abnormalities such as renal artery stenosis> 30%.
- renal angioplasty history, renal denervation, stent placement
- hemodynamically significant valvular heart disease
- an active systemic infection.
- renal artery of <4 mm.
- coagulation abnormalities.
Show all 9Show fewer
- kidney transplant or is waiting for a kidney transplant.
- life expectancy of less than 12 months (seatle score).
- femoral-iliac atherosclerotic
Trial locations and contacts
1 site in 1 country.
France1 site
Clinique Plein Ciel
Mougins, Alpes Maritimes, 06254
Jean Louis LLORET, MD
About this study
Official title: Evaluation à Six Mois du système de dénervation rénale Chez Les Patients Atteints d'Insuffisance Cardiaque
Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Both pharmacological and non-pharmacological intervention haven't shown to be effective in reducing morbidity and mortality of these patients when able to modulate the activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data have emphasized the potential role of sympathetic renal denervation in patient with hypertension. CHF per se but even more CHF associated with comorbity lead to significant increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as chemo or baroflex abnormalities. These patients usually suffer from conditions which do not allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic heart failure affects around 100 million people worldwild imposing a significant burden on health care system throughout the world. Even though symptoms are improved by heart failure therapy, they remain significantly disabling for many patients. Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. A new therapy directly targeting nerve traffic-renal artery denervation- has been shown to be effective in drug resistant hypertension, with an average drop in blood pressure of 33/12 mm hg.
The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral renal denervation with an intensive protocol of observation and assessment compring a 3 day hospital stay post procedure 3 and 6 months of regular outpatient follow-up.
Read the detailed description
Renal denervation is a new interventional cardiology technique that involves using a catheter and a femoral artery, inserting an RF probe that will destroy the nerve fibers in contact with the wall of the renal artery with a very small electric current.
The method utilizes the energy emitted by a miniaturized device positioned at the end of a catheter. This catheter is positioned in the arteries going to the kidneys.
Sympathetic overactivation, is reduced by renal denervation in drug-resistant hypertension. Several studies conducted in patients without heart failure showed that renal denervation reduces left ventricular hypertrophy beyond its only effect on blood pressure.
Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs.
The purpose of this Clinical investigation is to evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with chronique heart failure.
All patients will be on stable maximal tolerated pharmacological therapy for HFC prior to denervation.
After the procedure all patients will be monitored as inpatients for 3 days so that hemodynamic disturbances could be identified. Baseline measurements, including BNP, echo Doppler VO2 and six minutes walk test will be repeated before discharge from hospital.
After discharge patients will be followed up weekly for 4 weeks and then after 3 and 6 months. At the end of the study, bnp, echo Doppler Vo2 and six minutes walk test will be repeated, they also will be asked to categorize themselves as feeling worse, the same, or better in comparison to their preprocedural state.
- Conditions
- Chronic Heart Failure
- Being tested
- EnligHTN™ Renal Denervation System
- Keywords
- Cardio-Renal Syndrome, Chronic Heart Failure, Renal Denervation, Sympathetic activation, Heart Failure, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardio-Renal Syndrome, Heart Failure, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnligHTN™ Renal Denervation SystemDevice
Also called EnligHTN™ Renal Artery Ablation Catheter, EnligHTN™ RF Generator, EnligHTN™ Guiding Catheter
The renal nerve ablation will be performed according to the EnligHTN™ Renal Denervation System Instructions for Use. This system has the CE mark and is marketed in Europe and manufactured in France. The ablation catheter is indicated for use in renal denervation procedures for the treatment of hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | patients with chronique heart failure will undergo EnligHTN™ Renal Denervation System as a complementary treatment of their therapy Receives: Device: EnligHTN™ Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant improvement of the 6 minutes walk test
The primary efficacy end point is the assessment at 6 months post renal denervation of the improvement in symptomatology as BNP level or VO2 max or pharmacological therapy from baseline
Measured: 6 months
Secondary outcomes (2)
Incidence of adverse events
Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation Renal function change based on eGFR
Measured: 5 months
Quality of life evaluated by EQ-5D. 1
Measured: before intervention and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJan 2017
- Primary completionSep 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute Arnault Tzanck, France
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Jean Louis LLORET, MD, Principal investigator, Private hospital Mougins Arnault Tzanck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471729
- Sponsor's protocol ID
- P010215
- Acronym
- DENRENIC
- Status last verified
- Oct 2016
- First submitted
- 8 Jun 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation à Six Mois du système de dénervation rénale Chez Les Patients Atteints d'Insuffisance Cardiaque
- ClinicalTrials.gov ID
- NCT02471729
- Acronym / sponsor ID
- DENRENIC / P010215
- Conditions
- Chronic Heart Failure
- Keywords
- Cardio-Renal Syndrome, Chronic Heart Failure, Renal Denervation, Sympathetic activation, Heart Failure, Cardiovascular Diseases, Heart Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Institute Arnault Tzanck, FranceUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jan 2017
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 15 Jun 2015 (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.
Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Both pharmacological and non-pharmacological intervention haven't shown to be effective in reducing morbidity and mortality of these patients when able to modulate the activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data have emphasized the potential role of sympathetic renal denervation in patient with hypertension. CHF per se but even more CHF associated with comorbity lead to significant increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as chemo or baroflex abnormalities. These patients usually suffer from conditions which do not allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic heart failure affects around 100 million people worldwild imposing a significant burden on health care system throughout the world. Even though symptoms are improved by heart failure therapy, they remain significantly disabling for many patients. Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. A new therapy directly targeting nerve traffic-renal artery denervation- has been shown to be effective in drug resistant hypertension, with an average drop in blood pressure of 33/12 mm hg.
The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral renal denervation with an intensive protocol of observation and assessment compring a 3 day hospital stay post procedure 3 and 6 months of regular outpatient follow-up.
Detailed description
Renal denervation is a new interventional cardiology technique that involves using a catheter and a femoral artery, inserting an RF probe that will destroy the nerve fibers in contact with the wall of the renal artery with a very small electric current.
The method utilizes the energy emitted by a miniaturized device positioned at the end of a catheter. This catheter is positioned in the arteries going to the kidneys.
Sympathetic overactivation, is reduced by renal denervation in drug-resistant hypertension. Several studies conducted in patients without heart failure showed that renal denervation reduces left ventricular hypertrophy beyond its only effect on blood pressure.
Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs.
The purpose of this Clinical investigation is to evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with chronique heart failure.
All patients will be on stable maximal tolerated pharmacological therapy for HFC prior to denervation.
After the procedure all patients will be monitored as inpatients for 3 days so that hemodynamic disturbances could be identified. Baseline measurements, including BNP, echo Doppler VO2 and six minutes walk test will be repeated before discharge from hospital.
After discharge patients will be followed up weekly for 4 weeks and then after 3 and 6 months. At the end of the study, bnp, echo Doppler Vo2 and six minutes walk test will be repeated, they also will be asked to categorize themselves as feeling worse, the same, or better in comparison to their preprocedural state.
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: EnligHTN™ Renal Denervation Systempatients with chronique heart failure will undergo EnligHTN™ Renal Denervation System as a complementary treatment of their therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stable chronic heart failure
- NYHA III-IV
- LV EF <35 assessed by ultrasound
- EGFR> 45ml / min / 1.73m2
- Optimal therapeutic treatment
Key exclusion criteria (9 listed)
- significant renovascular abnormalities such as renal artery stenosis> 30%.
- renal angioplasty history, renal denervation, stent placement
- hemodynamically significant valvular heart disease
- an active systemic infection.
- renal artery of <4 mm.
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 |
|---|---|---|
| EnligHTN™ Renal Denervation SystemAlso: EnligHTN™ Renal Artery Ablation Catheter, EnligHTN™ RF Generator, EnligHTN™ Guiding CatheterThe renal nerve ablation will be performed according to the EnligHTN™ Renal Denervation System Instructions for Use. This system has the CE mark and is marketed in Europe and manufactured in France. The ablation catheter is indicated for use in renal denervation procedures for the treatment of hypertension. | Device | Renal Denervation |
Primary outcome
Significant improvement of the 6 minutes walk test
Time frame: 6 months
The primary efficacy end point is the assessment at 6 months post renal denervation of the improvement in symptomatology as BNP level or VO2 max or pharmacological therapy from baseline
2 secondary outcomes
Incidence of adverse events
Time frame: 5 months
Quality of life evaluated by EQ-5D. 1
Time frame: before intervention and after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Jean Louis LLORET, MD principal investigator
Private hospital Mougins Arnault Tzanck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EnligHTN™ Renal Denervation System in people with Chronic Heart Failure, run by Institute Arnault Tzanck, France at 1 site in France.
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 6 inclusion and 9 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 19 Oct 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 France. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jean Louis LLORET, MD (33 (0)4.97.16.65.17, jl.lloret@tzanck.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant improvement of the 6 minutes walk test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2016.