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

Sponsor
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Study ID
NCT05795400
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    10 mg tablets given once daily, per oral use
  • Placebo — DRUG
    tablet of placebo drug dosed once daily

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Apr 2026
Primary completion
May 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozine 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.
  • Placebo Comparator: Control group
    In the control group, patients will be treated with standard diuretic therapy without SGLT-2 inhibitors.

Primary Outcome Measure

Effect of dapagliflozin on quality of life using Kansas City Cardiomyopathy Questionnaire Summary Score (KCCQ-SC) [ Time Frame: 6 months ]

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