CompletedNot Applicable

Administration of the SGLT-2 Inhibitor Dapagliflozin in the Patients With Amyloid Cardiomyopathy

Russia50 participantsStarted 2022-06-01

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

Effect of dapagliflozin on quality of life using Kansas City Cardiomyopathy Questionnaire Summary Score (KCCQ-SC)

Timeframe: 6 months

Effect of Dapagliflozin on 6 Minute Walk Test Distance

Timeframe: 6 months

Effect of dapagliflozin on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)

Timeframe: 6 months

Trial details

NCT IDNCT05795400

SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction trials