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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
Drug Has Already Been Approved
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests a pill called empagliflozin in patients with a specific type of heart failure who also have diabetes or kidney disease. The pill helps lower blood sugar and may improve heart and kidney health by reducing inflammation.

Eligible Conditions
  • Transthyretin Amyloid Cardiomyopathy

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean Change in Body Weight
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
7%
Hypertension
7%
Hypotension
7%
Urinary tract infection
6%
Renal impairment
6%
Hyperkalaemia
6%
Fall
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Hyperuricaemia
4%
Anaemia
3%
Acute kidney injury
3%
Pneumonia
2%
COVID-19
2%
Death
2%
Acute myocardial infarction
2%
Cardiac failure congestive
1%
Basal cell carcinoma
1%
Cardiac failure chronic
1%
Cellulitis
1%
Syncope
1%
Chronic kidney disease
1%
COVID-19 pneumonia
1%
Ischaemic stroke
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Myocardial infarction
1%
Sepsis
1%
Transient ischaemic attack
1%
Angina unstable
1%
Cerebrovascular accident
1%
Angina pectoris
1%
Ventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,663,165 Total Patients Enrolled
Mathew Maurer, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
25 Total Patients Enrolled
~4 spots leftby Nov 2025
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