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Renal Denervation in Patients With Heart Failure Secondary to Chagas Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02099903
Recruitment Status : Unknown
Verified March 2014 by Pedro A. Lemos, InCor Heart Institute.
Recruitment status was:  Recruiting
First Posted : March 31, 2014
Last Update Posted : March 31, 2014
Johnson & Johnson
Information provided by (Responsible Party):
Pedro A. Lemos, InCor Heart Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure, Systolic Chagas Disease Chagas Cardiomyopathy Device: transcatheter renal denervation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Renal Denervation in Patients With Systolic Heart Failure Due to Chagas' Disease - a Safety and Efficacy Study.
Study Start Date : March 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Medical therapy for heart failure
Standard optimized medical therapy for heart failure.
Experimental: Renal denervation + medical therapy.
Transcatheter Renal Denervation with irrigated radiofrequency catheter + standard medical therapy.
Device: transcatheter renal denervation
Renal sympathetic denervation with an irrigated radiofrequency catheter.
Other Name: Celsius Thermocool (Biosense Webster, California, USA)

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction (LVEF) by echocardiography. [ Time Frame: 9 months. ]
  2. New York Heart Association (NYHA) functional class. [ Time Frame: 9 months. ]
  3. 6-minute walk test [ Time Frame: 9 months. ]
  4. Peak Oxygen consumption (VO2) by ergoespirometry. [ Time Frame: 9 months. ]

Other Outcome Measures:
  1. Change in serum B-type natriuretic peptide (BNP). [ Time Frame: 9 months. ]
  2. Quality of life assessed by Minnesota and EuroQOL five dimensions (EQ-5D)questionnaires. [ Time Frame: 9 months. ]
  3. Peripheral sympathetic activity measured by microneurography. [ Time Frame: 9 months. ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients ≥ 18 to ≤ 70 years of age with chronic systolic heart failure, Chagas disease etiology.
  2. Two positive serology results for Chagas by two distinct methods.
  3. NYHA (New York Heart Association) class II or III.
  4. Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure.
  5. LVEF (Left Ventricular Ejection Fraction) ≤ 40% (Simpson Method).

Exclusion Criteria:

  1. Patients with NYHA class I or IV.
  2. Sustained ventricular tachycardia (>30 sec) or with hemodynamic compromise.
  3. Presence of permanent pacemaker or implantable defibrillator.
  4. Systolic blood pressure < 90 mmHg.
  5. Heart beat < 60 bpm at rest.
  6. Advanced renal insufficiency (estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 square meters).
  7. Patients with planned cardiac surgery or percutaneous revascularization.
  8. Other reasons which would preclude the patient from participating in the study (comorbidities, life expectancy less than 1 year).
  9. Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent.
  10. Refusal of the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02099903

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Heart Institute - InCor. University of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Patricia Pereira    +55 11 2661-5368   
Principal Investigator: Pedro Lemos, MD PhD         
Sponsors and Collaborators
InCor Heart Institute
Johnson & Johnson
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Responsible Party: Pedro A. Lemos, Professor of Medicine, InCor Heart Institute Identifier: NCT02099903    
Other Study ID Numbers: 18400613.1.0000.0068
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Keywords provided by Pedro A. Lemos, InCor Heart Institute:
Heart Failure
Heart Failure, Systolic
Chagas Disease
Chagas Cardiomyopathy
Renal Denervation
Irrigated Radiofrequency Catheter
Additional relevant MeSH terms:
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Chagas Disease
Chagas Cardiomyopathy
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases