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

NCT02471729 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-10-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Institute Arnault Tzanck, France

    lead OTHER

Principal Investigators

  • Jean Louis LLORET, MD · Private hospital Mougins Arnault Tzanck

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-09-30
Completion
2018-01-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471729 on ClinicalTrials.gov