Administration of the SGLT-2 Inhibitor Dapagliflozin in the Patients With Amyloid Cardiomyopathy
Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring heart failure, amyloidosis, cardiomyopathy, amyloid cardiomyopathy
Eligibility Criteria
Inclusion Criteria: Males and females between 18 and 80 years of age HF, confirmed with the increased level of NT-proBNP>300 pg/mL or BNP>100 pg/mL Transthyretin amyloid cardiomyopathy, confirmed with echocardiography and/or contrast-enhanced cardiac MRI Exclusion Criteria: The inability to continue all the activities planned in this study by the patient. The onset of pregnancy. Patient's voluntary withdrawal of consent to participate in a clinical trial at any point during the conduct of the study. Development of intolerable side effects. Administration of disease-modifying treatment of amyloidosis.
Sites / Locations
- National Medical Research Center for Cardiology, Ministry of Health of Russian FederationRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dapagliflozine group
Control group
20 patients diagnosed with heart failure and amyloid cardiomyopathy, regardless of HF phenotype, are planned to be enrolled in the study. Patients with the edematous syndrome are allowed to participate in the study, but the condition of stable hemodynamics must be observed. Regardless of the group, patients will receive standard therapy for ADHF (diuretics and MRA). Patients will not receive beta-blockers/ACE-I/ARNI. In the treatment group the therapy will include the SGLT-2 inhibitor dapagliflozin, which will be prescribed during the first 24 hours after the hospitalization.
In the control group, patients will be treated with standard diuretic therapy without SGLT-2 inhibitors.