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Renal denervation in patients with heart failure secondary to Chagas' disease: A pilot randomized controlled trial
André G Spadaro1, Edimar A Bocchi1, Germano E Souza1
1Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.
Insights
Renal denervation appears safe and feasible for Chagas cardiomyopathy patients. This pilot study showed no significant difference in major adverse events between renal denervation and conservative treatment after nine months.
Area of Science:
- Cardiology
- Infectious Diseases
- Interventional Cardiology
Background:
- Chagas disease affects 6 million in Latin America, with 20-30% developing Chagas heart disease.
- Chagas heart disease involves myocarditis, neuronal depletion, and dysautonomy.
- Advanced Chagas cardiomyopathy presents with severe symptoms and reduced left ventricular function.
Purpose of the Study:
- To evaluate the safety and feasibility of renal denervation in patients with advanced symptomatic Chagas cardiomyopathy.
- To assess the incidence of major adverse events following renal denervation.
Main Methods:
- Open-label, prospective pilot study with a 2:1 randomization to renal denervation or conservative treatment.
- Primary endpoint: major adverse events at 9 months (composite of death, MI, stroke, renal intervention, or renal function decline).
- Included 17 patients with severe Chagas cardiomyopathy and low ejection fraction (average 26.7%).
Main Results:
- Renal denervation procedure was successful and uneventful in all patients.
- Major adverse events occurred in 36.4% of the renal denervation group vs. 50.0% in the control group (p = .6).
- Clinical, laboratory, functional, echocardiographic, and quality of life parameters were similar between groups at 9 months.
Conclusions:
- Renal denervation is a safe and feasible option for Chagas cardiomyopathy patients.
- Further research is needed to confirm the clinical efficacy of renal denervation in this high-risk population.
- This pilot study supports future investigations into interventional strategies for Chagas cardiomyopathy prognosis.
Introduction:
Chagas disease is one of the most relevant endemic parasitic diseases in Latin America, affecting approximately 6 million people. Overt Chagas heart disease is an ominous condition, occurring in 20-30% of infected individuals, which has besides the persistent myocarditis a peculiar intracardiac ganglionic neuronal depletion and dysautonomy. This study aims to evaluate the safety and feasibility of renal denervation for patients with advanced symptomatic Chagas cardiomyopathy.
Methods:
Open-label prospective pilot study that randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio). The primary endpoint was the incidence of major adverse events at 9 months, defined as a composite of all-cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function.
Results:
A total of 17 patients were allocated for renal denervation (n = 11) or conservative treatment (n = 6). Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7 ± 4.9%). For patients randomized to renal denervation, the procedure was performed successfully and uneventfully. After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6). After 9 months, clinical, laboratory, functional, echocardiographic, and quality of life parameters were similar between groups.
Conclusions:
This pilot study suggests that renal denervation is safe and feasible in patients with Chagas cardiomyopathy, warranting future studies to better evaluate the clinical efficacy of the interventional strategy in improving the prognosis of this high-risk population.