Empagliflozin for Congenital Heart Disease
(EmpaCHD Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Anita Saraf
Disqualifiers: Diabetes, Liver disease, Metabolic disorders, others
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are currently on Jardiance, you must not have taken it in the last 4 weeks to participate.
What data supports the effectiveness of the drug empagliflozin for congenital heart disease?
Empagliflozin, a drug originally used for diabetes, has been shown to reduce the risk of death and hospitalization in adults with heart failure, even if they don't have diabetes. It has also been effective in lowering the risk of hospitalization in people with heart failure and improving heart function, which may suggest potential benefits for congenital heart disease.
12345How does the drug empagliflozin differ from other treatments for congenital heart disease?
Empagliflozin is unique because it was originally developed to treat type 2 diabetes by helping the body excrete excess glucose through urine, but it has also been found to reduce the risk of heart failure and cardiovascular death. This makes it different from other treatments for congenital heart disease, which may not have these additional benefits.
12678Eligibility Criteria
Adults with congenital heart disease who may be experiencing heart failure can join this trial. Specific details about eligibility are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.Inclusion Criteria
Must be able to complete neurocognitive assessments on a handheld computer.
I am 18 years old or older.
I have been diagnosed with a heart condition present since birth.
+3 more
Exclusion Criteria
Pregnancy, breastfeeding, or planning to become pregnant in the coming year
I cannot take Jardiance/Entresto or certain heart failure medications due to adverse reactions.
Glomerular Filtration Rate <20
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Empagliflozin 10 mg or placebo daily for 1 year
52 weeks
Regular visits for monitoring and assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing Empagliflozin (Jardiance), a medication for heart failure, against a placebo in adults with congenital heart defects. The aim is to see if it's effective and safe for these patients.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin 10 MGExperimental Treatment1 Intervention
Empagliflozin 10 mg daily will be administered for 1 year. The patient and the PI will be blinded (unaware) of the group they are assigned to.
Group II: PlaceboPlacebo Group1 Intervention
Placebo for 1 year
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇺🇸 Approved in United States as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
🇨🇦 Approved in Canada as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇯🇵 Approved in Japan as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of PittsburghPittsburgh, PA
Magee Women's HospitalPittsburgh, PA
Presbyterian HospitalPittsburgh, PA
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Who Is Running the Clinical Trial?
Anita SarafLead Sponsor
The Pittsburgh FoundationCollaborator
References
Diabetes Drug Now Approved for Heart Failure. [2023]The diabetes drug empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure, even if they do not have diabetes.Nurses and NPs should monitor patients for adverse effects, especially fluid deficits.
Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">This is a summary of the article describing the EMPEROR-Reduced study of empagliflozin, which was published in the New England Journal of Medicine. Empagliflozin (brand name Jardiance®) is a new drug therapy for the treatment of chronic heart failure. Chronic heart failure is a long-term condition where the heart cannot pump enough blood around the body, leading to symptoms such as shortness of breath, fatigue and build-up of too much water in the body (fluid retention). It also increases the risk for premature death.
Anti-arrhythmic and inotropic effects of empagliflozin following myocardial ischemia. [2021]Empagliflozin (EMPA) reduces heart failure hospitalization and mortality. The benefit in terms of ventricular arrhythmia and contractility has not been explored.
Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. [2023]In the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease, in comparison with placebo, empagliflozin reduced the risks of 3-point major adverse cardiovascular events (3-point MACE), cardiovascular and all-cause death, and hospitalization for heart failure. We investigated whether these effects varied across the spectrum of baseline cardiovascular risk.
Rationale and design of the effects of EMpagliflozin on left ventricular DIAstolic function in diabetes (EmDia) study. [2023]Data of the EMPA-REG OUTCOME study have demonstrated a beneficial effect of the sodium-glucose cotransporter 2 inhibitor empagliflozin on cardiovascular outcome in patients with type 2 diabetes. The reduction in cardiovascular mortality and hospitalization due to heart failure might be in part explained by the direct effects of empagliflozin on cardiac diastolic function. The EmDia trial investigates the short-term effects of empagliflozin compared to placebo on the left ventricular E/E' ratio as a surrogate of left ventricular diastolic function.
New Insights into the Use of Empagliflozin-A Comprehensive Review. [2023]Empagliflozin is a relatively new drug that, as an inhibitor of the sodium−glucose cotransporter 2 (SGLT2), causes increased urinary glucose excretion and thus contributes to improved glycemic control, better glucose metabolism, reduced glucotoxicity and insulin resistance. Although its original use was to induce a hypoglycemic effect in patients with type 2 diabetes mellitus (T2DM), empagliflozin has also shown a number of other beneficial effects by demonstrating a nephroprotective effect, and it has proven to be a breakthrough in the treatment of heart failure (HF). Empagliflozin has been shown to reduce hospitalizations for HF and the number of deaths from cardiovascular causes. Empagliflozin treatment also reduces the incidence of renal events, including death from renal causes, as well as the risk of end-stage renal failure. Empagliflozin appears to be a fairly well-tolerated and safe drug. In patients with inadequate glycemic control, empagliflozin used in monotherapy or as an adjunct to therapy effectively lowers fasting blood glucose, postprandial blood glucose, average daily glucose levels, glycated hemoglobin A1C (HbA1C) and also leads to significant weight reduction in patients with T2DM. Unfortunately, there are some limitations, e.g., severe hypersensitivity reaction to the drug and a glomerular filtration rate (GFR)
[Empagliflozin - the new representative of SGLT2 transporter inhibitors for the treatment of patients with diabetes 2 type]. [2018]Empagliflozin is a new medicine used to reduce hyperglycemia in patients with type 2 diabetes. It belongs to the most advanced class of antidiabetic drugs, known as gliflozins, which prevent reabsorption of glucose through inhibiting SGLT2 sodium-glucose cotransporter. Thereby they cause therapeutic glycosuria, thanks to which a loss of approximately 70 g of glucose per day occurs. This not only effects the decrease in glycemia, but also the loss of body mass, since this excreted glucose cannot be used as an energetic substrate. The studies within phase 3 have proven the therapeutic efficacy of empagliflozin in monotherapy, in combination with the other oral antidiabec drugs and insulin. Another favourable effect of empagliflozin is a slight decrease in blood pressure. In May 2014, empagliflozin was approved for the treatment of patients with type 2 diabetes within the European Union 2014, since October 2014 it has been available in the Czech Republic and since 1 February 2015 empagliflozin (under the trade name Jardiance®) has been partially covered by the health insurance for the treatment of patients with type 2 diabetes either in combination with metformin or in combination with insulin (with or without metformin).
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]Empagliflozin is a new inhibitor of sodiumglucose cotransporters type 2 (SGLT2) for the treatment of type 2 diabetes mellitus (T2DM). Its specific action inhibits glucose reabsorption in renal tubules and thus promotes glucosuria. This effect results in a reduction in fasting and postprandial glycaemia and a decrease of glycated haemoglobin (HbA(Ic)), independently of insulin. Furthermore, calorie urinary loss promotes weight reduction and osmotic diuresis lowers arterial blood pressure. The efficacy of empagliflozin increases according to the level of hyperglycaemia but decreases in patients with renal insufficiency. In 24 to 104-week controlled trials versus placebo, empagliflozin reduces HbA(1c) (approximately 0.8%), without hypoglycaemia (except in patients already treated with insulin or sulphonylureas). This improvement in glucose control is rather similar to that observed with active comparators (metformin, glimepiride or sitagliptin), with the advantage for empagliflozin of reducing body weight (approximately 2 kg) and blood pressure (systolic approximately 4 mm Hg and diastolic approximately 2 mm Hg). Empagliflozin has shown a cardiovascular protection in the EMPA-REG OUTCOME trial. Mycotic genital infections occur more frequently, especially in women, while a negligible increase in mild urinary tract infections may be observed. The risk of hypotension and volume depletion is low, although it should be carefully checked in more fragile and at risk patients. Empagliflozin (Jardiance), which is commercialized at the doses of 10 mg and 25 mg once daily, is indicated for the treatment of T2DM and reimbursed in Belgium with conditions as add-on to a background glucose-lowering therapy.