CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Empagliflozindrug
Likely dose
Empagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05233163
NCT05233163Phase 4Completed

Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors in Transthyretin Amyloid (ATTR) Cardiomyopathy

Columbia University·interventional·Posted Feb 10, 2022·Updated Aug 6, 2024

In Brief

A Phase 4 clinical trial evaluating Empagliflozin for Transthyretin Amyloid Cardiomyopathy. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This is a single center, single arm, prospective, 12 week open label pilot trial of the sodium-glucose cotransporter 2 inhibitor (SGLT2i), empagliflozin 10 mg oral daily, in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). The target population for enrollment will be subjects with ATTR-CM and either non-insulin dependent diabetes mellitus or chronic kidney disease. The primary aim will be to assess the safety and tolerability of empagliflozin 10 mg oral daily in subjects with heart failure secondary to ATTR, which remain unexplored. The accrual target is 15 subjects. Consented subjects will be evaluated for safety and tolerability of study drug, empagliflozin 10 mg oral daily, over a period of 12 weeks. Subjects will undergo a total of 6 study visits: 3 in-person and 3 telephone follow-ups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedFeb 10, 2022
Enrollment StartMar 14, 2022
Primary CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.4 years ago

Interventions

Empagliflozindrug

Empagliflozin 10 mg oral daily for 12 weeks