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Effect of dapagliflozin on the quality of life and exercise capacity of patients with amyloid transthyretin cardiac amyloidosis: a pilot, phase 2b study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504041-31-00
Acronym
DAMI
Enrollment
50
Registered
2023-06-23
Start date
2023-11-17
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ATTR Cardiac Amyloidosis

Brief summary

Absolute change in 6 minute walking distance

Detailed description

Proportion of patients experiencing a clinically significant increase in the Kansas City Cardiomyopathy Questionnaire overall summary score (≥5 points), Proportion of patients with meaningful change in NT-proBNP (≥20% decrease);, Any decrease in diuretic dose;, Evaluate the safety profile of dapagliflozin, in terms of adverse events recorded, compared to the SOC.

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

Fondazione Toscana Gabriele Monasterio
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Absolute change in 6 minute walking distance

Secondary

MeasureTime frame
Proportion of patients experiencing a clinically significant increase in the Kansas City Cardiomyopathy Questionnaire overall summary score (≥5 points), Proportion of patients with meaningful change in NT-proBNP (≥20% decrease);, Any decrease in diuretic dose;, Evaluate the safety profile of dapagliflozin, in terms of adverse events recorded, compared to the SOC.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026