← Back to Search

SGLT2 Inhibitor

Empagliflozin for Heart Transplant Recipients

Phase 4

Waitlist Available

Led By Josef Stehlik, MD MPH

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Baseline UACR <30 mg/g in patients without T2D

eGFR <20 mL/min/1.73m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to study the effects of a drug called empagliflozin on kidney function, heart health, blood cell production, and overall physical well-being in veterans who have undergone heart trans

Who is the study for?

This trial is for heart transplant recipients who may have kidney, cardiovascular, or metabolic issues due to their condition and post-transplant medications. It's specifically designed for Veterans who've undergone a heart transplant.

What is being tested?

The study tests whether empagliflozin can improve kidney function, reduce the risk of heart and metabolic diseases, boost red blood cell production, and enhance overall physical health in these patients compared to a placebo.

What are the potential side effects?

While not specified here, SGLT2 inhibitors like empagliflozin typically can cause urinary tract infections, dehydration leading to low blood pressure, ketoacidosis (a serious diabetes complication), genital yeast infections, and increased cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My urine protein levels are low and I don't have type 2 diabetes.

Select...

My kidney function is severely reduced.

Select...

I have type 1 diabetes.

Select...

I have an infection that is not under control.

Select...

I have had a transplant involving multiple organs.

Select...

I am not pregnant, breastfeeding, or if of childbearing age, I am using birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Urinary albumin-to-creatinine ratio (UACR)

Secondary study objectives

Body weight

Estimated Glomerular Filtration Rate (eGFR)

Fasting blood glucose

+14 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951

15%

Cardiac failure

Hypertension

Hypotension

Urinary tract infection

Renal impairment

Hyperkalaemia

Fall

Atrial fibrillation

Diabetes mellitus

Hyperuricaemia

Anaemia

Acute kidney injury

Pneumonia

COVID-19

Death

Acute myocardial infarction

Cardiac failure congestive

Cardiac failure chronic

Cellulitis

Syncope

Chronic kidney disease

COVID-19 pneumonia

Ischaemic stroke

Coronary artery disease

Basal cell carcinoma

Chronic obstructive pulmonary disease

Myocardial infarction

Sepsis

Transient ischaemic attack

Angina unstable

Cerebrovascular accident

Angina pectoris

Ventricular tachycardia

100%

80%

60%

40%

20%

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EmpagliflozinExperimental Treatment1 Intervention

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin

2017

Completed Phase 4

~181750

0 / 7Eligibility criteria met