Chronic Heart Failure Clinical Trial
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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