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Chagas' cardioneuropathy: effect of ganglioside treatment in chronic dysautonomic patients--a randomized,
D Iosa1, D C Massari, F C Dorsey
1Centro Privado de Medicina, Fidia Pharmaceutical Corp., Còrdoba, Argentina.
Insights
Cronassial, a mixed gangliosides treatment, shows promise for Chagas
Area of Science:
- Cardiology
- Neurology
- Pharmacology
Background:
- Chagas' disease causes cardioneuropathy, leading to heart failure and sudden death.
- Currently, no effective pharmacological treatments exist for this condition.
Purpose of the Study:
- To evaluate the safety and efficacy of Cronassial (mixed gangliosides) in treating Chagas' cardioneuropathy.
- To assess Cronassial's impact on autonomic nervous system function and related symptoms.
Main Methods:
- A placebo-controlled clinical trial involving 58 adults with Chagas' disease and autonomic dysfunction.
- Participants received daily intramuscular injections of Cronassial (40 mg) or placebo for 4 or 8 weeks.
- Evaluated outcomes included autonomic responses to stress, dizziness, arrhythmias, and T-lymphocyte counts.
Main Results:
- Cronassial was found to be safe and well-tolerated.
- Significant improvements were observed in systolic blood pressure response to postural stress (p=0.050) and hyperventilation heart rate response (p=0.007).
- Cronassial significantly reduced dizziness (p<0.001), stress-induced arrhythmias (p=0.033), and increased PAS-positive T-lymphocyte counts (p<0.001) compared to placebo.
Conclusions:
- Cronassial demonstrates significant therapeutic potential for managing Chagas' cardioneuropathy.
- The drug effectively improves autonomic nervous system function and reduces key clinical manifestations of the disease.
Abstract:
To date, there is no effective pharmacologic treatment for Chagas' cardioneuropathy, one of the most common causes of congestive heart failure and sudden death in the world. Fifty-eight adults with positive serology for Chagas' disease and abnormal autonomic nervous system tests participated in this placebo-controlled clinical trial with Cronassial (mixed gangliosides), 40 mg daily intramuscular injection for 4 or 8 weeks. We measured postural response (heart rate, systolic and diastolic arterial blood pressure changes in response to standing); heart rate changes induced by cough and hyperventilation reflex tests; dizziness on standing; number of stress-induced arrhythmias; and periodic acid-Schiff (PAS)-positive T-lymphocyte percentage in blood samples. Cronassial is safe and significantly improves systolic blood pressure (p = 0.050) and double product responses to postural stress (p = 0.028), hyperventilation heart rate response (p = 0.007), frequency of dizziness episodes (p less than 0.001), number of arrhythmias (p = 0.033), and percentage of PAS-positive T-lymphocyte counts (p less than 0.001) compared with placebo.
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