Chronic Heart Failure Clinical Trial
— DENRENICOfficial 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.
Status | Not yet recruiting |
Enrollment | 12 |
Est. completion date | January 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Clinique Plein Ciel | Mougins | Alpes Maritimes |
Lead Sponsor | Collaborator |
---|---|
Institute Arnault Tzanck, France | St. Jude Medical |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | Quality of life evaluated by EQ-5D. 1 | before intervention and after 6 months | No |
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