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Renal Denervation in Patients With Heart Failure Secondary to Chagas Disease

Brazil30 participantsStarted 2014-03

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Patients with NYHA class I or IV.
✕. Sustained ventricular tachycardia (\>30 sec) or with hemodynamic compromise.
✕. Presence of permanent pacemaker or implantable defibrillator.
✕. Systolic blood pressure \< 90 mmHg.
✕. Heart beat \< 60 bpm at rest.
✕. Advanced renal insufficiency (estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73 square meters).
✕. Patients with planned cardiac surgery or percutaneous revascularization.
✕. Other reasons which would preclude the patient from participating in the study (comorbidities, life expectancy less than 1 year).

What they're measuring

Composite: death, myocardial infarction, cerebrovascular event, need of intervention on renal arteries and renal function impairment (decrease in estimated GFR > 30% from baseline).

Timeframe: 30 days.

Trial details

NCT IDNCT02099903

SponsorInCor Heart Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

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