SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05233163
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin 10 mg oral daily for 12 weeks

Study Details

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.

Key Dates

Start date
Mar 14, 2022
Status verified
Jul 2024
Primary completion
May 1, 2023
Completion
May 1, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Drug Arm
    Subjects will take empagliflozin 10 mg oral daily for 12 weeks.

Primary Outcome Measure

Number of Participants Who Experienced a Serious Adverse Event (SAE) [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital· New York, NY

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