Clinical trial

Administration of the SGLT-2 Inhibitor Dapagliflozin in the Patients With Amyloid Cardiomyopathy: a Pilot Study

Name

20230120

Description

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.

Trial arms

Trial start

2022-06-01

Estimated PCD

2025-01-01

Trial end

2025-06-01

Status

Recruiting

Treatment

Dapagliflozin 10mg Tab

10 mg tablets given once daily, per oral use

Arms:

Dapagliflozine group

Placebo

tablet of placebo drug dosed once daily

Arms:

Control group

Size

Primary endpoint

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

6 months

Effect of Dapagliflozin on 6 Minute Walk Test Distance

6 months

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

6 months

Eligibility criteria

Inclusion Criteria: 1. Males and females between 18 and 80 years of age 2. HF, confirmed with the increased level of NT-proBNP\>300 pg/mL or BNP\>100 pg/mL 3. Transthyretin amyloid cardiomyopathy, confirmed with echocardiography and/or contrast-enhanced cardiac MRI Exclusion Criteria: 1. The inability to continue all the activities planned in this study by the patient. 2. The onset of pregnancy. 3. Patient's voluntary withdrawal of consent to participate in a clinical trial at any point during the conduct of the study. 4. Development of intolerable side effects. 5. Administration of disease-modifying treatment of amyloidosis.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a single-center, pilot, prospective, randomized, placebo-controlled clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-04-03

1 organization

1 product

1 drug

4 indications

Organization

National Medical Research Center for Cardiology

Product

Dapagliflozin

Indication

Heart Failure with Reduced Ejection Fraction