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NCT05233163 · ClinicalTrials.gov registry record · Phase 4
SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy
A Phase 4 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT05233163 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 15 participants.
The verdict
NCT05233163, a Phase 4 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DRUG Empagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2023-05-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05233163
The ClinicalTrials.gov registry entry for NCT05233163 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Empagliflozin is the first listed.
NCT05233163 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05233163 about?
NCT05233163 is a clinical study titled "SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy". 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-...
What is the current status of trial NCT05233163?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2022-03-14. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT05233163?
The interventions under investigation include: Empagliflozin (DRUG).
Who is sponsoring clinical trial NCT05233163?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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