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Administration of the SGLT-2 Inhibitor Dapagliflozin in the Patients With Amyloid Cardiomyopathy: a Pilot Study
Efficacy and safety of early administration of the SGLT-2 inhibitor dapagliflozin will be evaluated in patients with HF, regardless of LVEF, due to amyloid cardiomyopathy.
Details
| Lead sponsor | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | 2022-06-01 |
| Completion | 2025-09-30 |
Conditions
- Heart Failure With Reduced Ejection Fraction
- Heart Failure With Preserved Ejection Fraction
- Heart Failure With Mid Range Ejection Fraction
- Amyloid Cardiomyopathy
Interventions
- Dapagliflozin 10mg Tab
- Placebo
Primary outcomes
- Effect of dapagliflozin on quality of life using Kansas City Cardiomyopathy Questionnaire Summary Score (KCCQ-SC) — 6 months
Changes in KCCQ score will be assessed - Effect of Dapagliflozin on 6 Minute Walk Test Distance — 6 months
Changes in 6MWT score will be assessed - Effect of dapagliflozin on N-terminal Pro B-type Natriuretic Peptide (NTproBNP) — 6 months
Changes in concentration of NT-proBNP will be assessed
Countries
Russia