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Status unknownNCT02099903Updated Mar 31, 2014

Renal Denervation in Patients With Heart Failure Secondary to Chagas Disease

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

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Heart Failure, Systolic
  • Chagas Disease
  • Chagas Cardiomyopathy

Keywords

  • Heart Failure
  • Heart Failure, Systolic
  • Chagas Disease
  • Chagas Cardiomyopathy
  • Renal Denervation
  • Irrigated Radiofrequency Catheter
03

In context

Chagas 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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • Devicetranscatheter renal denervation

    Renal sympathetic denervation with an irrigated radiofrequency catheter.

    Also known as: Celsius Thermocool (Biosense Webster, California, USA)

06

What researchers measure

Primary outcomes

  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 outcomes

  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 outcomes

  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.

07

Study locations

1 of 1 sites recruiting
  • Heart Institute - InCor. University of Sao Paulo Medical School
    Sao Paulo, 05403-000, Brazil
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02099903
Lead sponsor
InCor Heart Institute
Collaborators
Johnson & Johnson
Responsible party
Pedro A. Lemos (Professor of Medicine, InCor Heart Institute) — Principal investigator
First posted
Mar 31, 2014
Start date
Mar 2014
Primary completion
Dec 2014 (estimated)
Completion
Aug 2015 (estimated)
Last update
Mar 31, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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