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

NCT02471729 | Unknown Phase 1 DMC

• 1 other identifier: P010215
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Heart Failure

Keywords

Cardio-Renal Syndrome; Chronic Heart Failure; Renal Denervation; Sympathetic activation; Heart Failure; Cardiovascular Diseases; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of adverse events

  5 months

• Quality of life evaluated by EQ-5D. 1

  before intervention and after 6 months

Study Arms (1)

Renal Denervation

EXPERIMENTAL

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

Device: EnligHTN™ Renal Denervation System

Interventions

EnligHTN™ Renal Denervation System DEVICE

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.

Also known as: EnligHTN™ Renal Artery Ablation Catheter, EnligHTN™ RF Generator, EnligHTN™ Guiding Catheter

Renal Denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute Arnault Tzanck, France: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Clinique Plein Ciel

Mougins, Alpes Maritimes, 06254, France

Location

MeSH Terms

Conditions

Cardio-Renal Syndrome; Heart Failure; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jean Louis LLORET, MD

  Private hospital Mougins Arnault Tzanck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Louis LLORET, MD

CONTACT

33 (0)4.97.16.65.17; jl.lloret@tzanck.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 15, 2015
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 19, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)