An interventional study of transcatheter renal denervation in Heart Failure, Heart Failure, Systolic and Chagas Disease, sponsored by InCor Heart Institute. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-03-31.
Sponsored by InCor Heart Institute · Not applicable, Interventional, and Treatment
It is a randomized prospective controlled study of transcatheter renal denervation in patients with systolic heart failure secondary to Chagas' disease. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Chagas heart disease, due to reduction in renal and systemic sympathetic activity.
The activation of the sympathetic nervous system is one of the main mechanisms involved in heart failure pathophysiology, as well as activation of the renin-angiotensin-aldosterone system. These compensatory mechanisms are initially beneficial, in order to restore adequate cardiac output. Their long-term activation, nevertheless, leads to several deleterious effects on cardiovascular system, such as direct myocite lesion, cardiac hypertrophy, myocardial ischemia, oxidative stress, cardiac arrhythmias and myocite apoptosis, among others.
It has been widely demonstrated that modulation of sympathetic nervous system is an important therapeutic target for the treatment of systolic heart failure. Beta-blocker and ACE inhibitors therapies are the main stem of heart failure treatment and have demonstrated reduction in morbidity and mortality of this condition. Despite optimized medical treatment, heart failure carries a poor prognosis.
Surgical sympathectomy has been used decades ago for the treatment of malignant hypertension and showed marked reduction in arterial pressure. However, these procedures were very aggressive and lead to long hospitalization and recovery periods, as well as several limiting adverse effects. Recently, transcatheter renal denervation has evolved as a promising and less invasive technique, which allows destruction of renal nerves located on the adventitia of the renal arteries. The ablation procedure is performed by delivery of radiofrequency energy from the tip of a catheter positioned into the renal arteries, through standard femoral artery catheterization, a less morbid and safer approach.
Renal denervation has been tested mainly in patients with resistant hypertension, among other indications, with promising results. The pathophysiological basis for this treatment in hypertension, as well as heart failure, stands on the participation of renal afferent and efferent nerves on the maintenance of elevated systemic vascular resistance. Activation of efferent nerves leads to excretion o renin, aldosterone, angiotensin II, elevated norepinephrine levels and consequent retention of salt and water and reduction of renal blood flow. This mechanism and also afferent renal nerves activation contributes to the elevation of sympathetic tonus on the central nervous system.
In animal models of heart failure, renal denervation demonstrated improvement on renal and cardiac function. Initial clinical studies suggest that this intervention is safe and potentially effective on the treatment of heart failure in humans. Chagas heart disease is a prevalent cause of heart failure in Brazil and shares several pathophysiological aspects described for other causes of heart failure. Our aim is to evaluate the safety and effectiveness of renal denervation in systolic heart failure due to Chagas Heart disease.
68 studies on the registry are indexed under Chagas Disease; 4 are open to participants now.
This study's planned enrollment of 30 is below the median of 87 across 45 interventional studies indexed under Chagas Disease.
Browse Chagas Disease studies →InCor Heart Institute is the lead sponsor of 26 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard optimized medical therapy for heart failure.
Transcatheter Renal Denervation with irrigated radiofrequency catheter + standard medical therapy.
Device: transcatheter renal denervation
Renal sympathetic denervation with an irrigated radiofrequency catheter.
Also known as: Celsius Thermocool (Biosense Webster, California, USA)
Composite: death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline).
Time frame: 30 days.
Left Ventricular Ejection Fraction (LVEF) by echocardiography.
Time frame: 9 months.
New York Heart Association (NYHA) functional class.
Time frame: 9 months.
6-minute walk test
Time frame: 9 months.
Peak Oxygen consumption (VO2) by ergoespirometry.
Time frame: 9 months.
Change in serum B-type natriuretic peptide (BNP).
Time frame: 9 months.
Quality of life assessed by Minnesota and EuroQOL five dimensions (EQ-5D)questionnaires.
Time frame: 9 months.
Peripheral sympathetic activity measured by microneurography.
Time frame: 9 months.
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
InCor Heart Institute