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SGLT2 Inhibitor

Empagliflozin for Transthyretin Amyloid Cardiomyopathy

Phase 4

Waitlist Available

Led By Mathew Maurer, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks and 12 weeks

Awards & highlights

Study Summary

This trial will explore the safety and tolerability of a new drug, empagliflozin, in people with heart failure caused by ATTR.

Eligible Conditions

Transthyretin Amyloid Cardiomyopathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serious Adverse Event (SAE) Rate

Secondary outcome measures

Mean Change in Body Weight (kg)

Mean Change in Daily Diuretic Dose

Mean Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

+2 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951

15%

Cardiac failure

Hypertension

Urinary tract infection

Hypotension

Hyperkalaemia

Fall

Renal impairment

Atrial fibrillation

Diabetes mellitus

Anaemia

Hyperuricaemia

Acute kidney injury

Pneumonia

Acute myocardial infarction

COVID-19

Cardiac failure congestive

Death

Myocardial infarction

Cardiac failure chronic

Angina pectoris

Angina unstable

Ventricular tachycardia

COVID-19 pneumonia

Cellulitis

Sepsis

Chronic kidney disease

Coronary artery disease

Chronic obstructive pulmonary disease

Basal cell carcinoma

Cerebrovascular accident

Ischaemic stroke

Syncope

Transient ischaemic attack

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Empagliflozin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study Drug ArmExperimental Treatment1 Intervention

Subjects will take empagliflozin 10 mg oral daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,816 Total Patients Enrolled

Mathew Maurer, MDPrincipal InvestigatorColumbia University

1 Previous Clinical Trials

25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned the use of Empagliflozin?

"Evidence from a Phase 4 trial earned empagliflozin a rating of 3 on Power’s safety scale, as it is an officially approved medication."

Answered by AI

Are there any vacancies remaining for individuals to participate in this trial?

"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was first posted on March 14th 2022, is presently enrolling participants. A total of 15 patients must be recruited from a single location for the trial to proceed."

Answered by AI

How many participants are being considered for this trial at maximum capacity?

"Affirmative. Per the information on clinicaltrials.gov, this biomedical investigation is presently recruiting participants and was first published on March 14th 2022. As of right now, 15 patients are sought after from a solitary medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy

Mathew S. Maurer 2022. "SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233163.