Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: ANSWER-HF.
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Chagas disease is considered by the World Health Organization (WHO) as one of the most
neglected tropical diseases in the world, having relevance in many Latin America countries.
In addition, it already affects North America, Europe, Asia and Oceania. Some studies suggest
that chagasic heart failure has a worse prognosis, with up to 50% shorter survival than other
etiologies. The PARADIGM-HF (Prospective Comparison of Angiotensin Receptor
Blocker-Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact
on Global Mortality and Morbidity in Heart Failure) study showed 20% reduction in mortality
comparing sacubitril/valsartan with the standard treatment with ACE (angiotensin converting
enzyme) inhibitors. In the scenario of chagasic cardiomyopathy, a post hoc analysis of
PARADGIM-HF was reported on 113 patients. Reduced risk of cardiovascular death or
hospitalization for HF was noted in the group treated with sacubitril/valsartan. Attention
was drawn the study's limitations that included the small number of patients and reduced
statistical power. Therefore, the benefit of this new class remains uncertain in heart
failure due to Chagas cardiomyopathy. The ANSWER-HF Trial will be a clinical, randomized,
single-center, prospective, double-blind, controlled study. It will include 200 consecutive
participants with Chagas cardiomyopathy and left ventricular ejection fraction less than 40%
randomized independently. The objective of this study is to evaluate the benefit of
sacubitril/valsartan compared with enalapril in patients with heart failure due to Chagas
cardiomyopathy, with reduced ejection fraction. The primary endpoint of the study is the
change of left ventricular ejection fraction determined by transthoracic echocardiography.
Secondary endpoints include: assessment of ventricular arrhythmias; evaluation of functional
class; assessment of functional capacity; assessment of ventricular remodeling; and
evaluation of biomarkers. The patients will be followed for 6 months after treatment start.
All patients will be undergone to Doppler Echocardiography, 24-hour Holter, 6-minute walk
test, Biochemical and hematological exams and Biomarkers at the baseline and after 6 months.
Phase:
Phase 3
Details
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborator:
InCor Heart Institute
Treatments:
Angiotensin-Converting Enzyme Inhibitors Enalapril Enzyme Inhibitors LCZ 696 Sacubitril and valsartan sodium hydrate drug combination Valsartan