Effect at 6 Months of Renal Denervation in Chronic Heart Failure d'Insuffisance Cardiaque (DENRENIC)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: EnligHTN™ Renal Denervation System

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Alpes Maritimes
    • Mougins, Alpes Maritimes, France, 06254
      • Clinique Plein Ciel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Stable chronic heart failure
• NYHA III-IV
• LV EF <35 assessed by ultrasound
• EGFR> 45ml / min / 1.73m2
• Optimal therapeutic treatment
• IMC : 17-24

Exclusion Criteria:

• 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.
• kidney transplant or is waiting for a kidney transplant.
• life expectancy of less than 12 months (seatle score).
• femoral-iliac atherosclerotic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Renal Denervation; patients with chronique heart failure will undergo EnligHTN™ Renal Denervation System as a complementary treatment of their therapy

Device: EnligHTN™ Renal Denervation System; 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.; Other Names: EnligHTN™ Renal Artery Ablation Catheter; EnligHTN™ RF Generator; EnligHTN™ Guiding Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 months
Quality of life evaluated by EQ-5D. 1		before intervention and after 6 months

Collaborators and Investigators

• Sponsor: Institute Arnault Tzanck, France
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Jean Louis LLORET, MD, Private hospital Mougins Arnault Tzanck

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiovascular Diseases; Chronic Heart Failure; Heart Diseases; Renal Denervation; Sympathetic activation; Cardio-Renal Syndrome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: P010215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No