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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 belowSelect...
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
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 moreSide effects data
From 2021 Phase 3 trial • 5988 Patients • NCT0305795115%
Cardiac failure
7%
Hypotension
7%
Hypertension
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.
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,666 Total Patients Enrolled
Josef Stehlik, MD MPHPrincipal InvestigatorVA Salt Lake City Health Care System, Salt Lake City, UT
1 Previous Clinical Trials
208 Total Patients Enrolled