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

NCT05795400 | Completed DMC

• 1 other identifier: 20230120
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction; Heart Failure With Mid Range Ejection Fraction; Amyloid Cardiomyopathy

Keywords

heart failure; amyloidosis; cardiomyopathy; amyloid cardiomyopathy

Outcome Measures

Primary Outcomes (3)

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

  Changes in KCCQ score will be assessed

  6 months

• Effect of Dapagliflozin on 6 Minute Walk Test Distance

  Changes in 6MWT score will be assessed

  6 months

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

  Changes in concentration of NT-proBNP will be assessed

  6 months

Secondary Outcomes (3)

• Cardiovascular death + number of hospitalizations due to heart failure

  6 months

• Effect of dapagliflozin on change in echocardiographic parameters

  6 months

• Effect of dapagliflozin on change in specle-tracking echocardiographic parameters

  6 months

Study Arms (2)

Dapagliflozine group

EXPERIMENTAL

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.

Drug: Dapagliflozin 10mg Tab

Control group

PLACEBO COMPARATOR

In the control group, patients will be treated with standard diuretic therapy without SGLT-2 inhibitors.

Drug: Placebo

Interventions

Dapagliflozin 10mg Tab DRUG

10 mg tablets given once daily, per oral use

Dapagliflozine group

Placebo DRUG

tablet of placebo drug dosed once daily

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: lead

Study Sites (1)

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

Moscow, 121552, Russia

Location

Related Links

• Published article after the study

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure; Amyloidosis; Cardiomyopathies

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: a single-center, pilot, prospective, randomized, placebo-controlled clinical trial

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: April 3, 2023
• Study Start: June 1, 2022
• Primary Completion: May 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

RU (1)