SGLT2 Inhibitors for Heart Failure With LVADs
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Chicago
Disqualifiers: Type 1 diabetes, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug SGLT2 inhibitors for heart failure?
SGLT2 inhibitors, like empagliflozin and dapagliflozin, have been shown in large clinical trials to reduce the risk of heart failure hospitalizations and improve heart health in patients, even those without diabetes. These drugs are now considered important in treating heart failure with reduced ejection fraction, as they have demonstrated benefits in cardiovascular outcomes.12345
What is the safety profile of SGLT2 inhibitors in humans?
SGLT2 inhibitors, used for conditions like type 2 diabetes and heart failure, generally have a favorable safety profile but can cause some side effects. Common issues include mild infections and dehydration, while more serious but rare risks include diabetic ketoacidosis, low blood sugar (when combined with insulin), and lower limb problems. Monitoring is important to manage these potential side effects.678910
How do SGLT2 inhibitors work differently from other drugs for heart failure?
SGLT2 inhibitors, originally developed for diabetes, are unique because they help manage heart failure by reducing hospitalizations and improving heart function, even in patients without diabetes. They work by affecting glucose and sodium levels in the kidneys, which can lead to benefits like weight loss, lower blood pressure, and improved heart and kidney health.12111213
Eligibility Criteria
This trial is for adults over 18 with heart failure who have a left ventricular assist device (LVAD) implanted and haven't been treated with SGLT2 inhibitors yet. They must be able to consent and have an eGFR of at least 30 ml/min/1.73 m². Those with Type 1 diabetes or worse kidney function can't join.Inclusion Criteria
I have not been treated with SGLT2 inhibitors.
Your kidney function is good, with a filtration rate of at least 30 milliliters per minute per 1.73 square meters.
I am 18 years old or older.
See 2 more
Exclusion Criteria
My kidney function is severely reduced.
I have been diagnosed with Type 1 diabetes.
I am under 18 years old.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either SGLT2i or no SGLT2i as part of routine heart failure care for 6 months
6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- SGLT2i (SGLT2 inhibitor)
Trial OverviewThe study is looking at the effects of sodium-glucose co-transporter 2 inhibitors (SGLT2i) on patients with heart failure who use LVADs, comparing those who take SGLT2i against those who do not.
Participant Groups
2Treatment groups
Active Control
Group I: SGLT2iActive Control1 Intervention
Participants will be asked to take an SGLT2i for 6 months. The SGLT2i and heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.
Group II: No SGLT2iActive Control1 Intervention
Participants will not be asked to take an SGLT2i. Heart failure care will be managed according to routine care, and data will be collected from the participant's medical record.
SGLT2i is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as SGLT2 inhibitors for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
- Cardiovascular risk reduction
🇪🇺 Approved in European Union as SGLT2 inhibitors for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
- Cardiovascular risk reduction
🇨🇦 Approved in Canada as SGLT2 inhibitors for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
- Cardiovascular risk reduction
🇯🇵 Approved in Japan as SGLT2 inhibitors for:
- Type 2 diabetes
- Heart failure
- Chronic kidney disease
- Cardiovascular risk reduction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
ANMCO statement on the use of sodium-glucose cotransporter 2 inhibitors in patients with heart failure: a practical guide for a streamlined implementation. [2022]Sodium-glucose cotransporter 2 (SGLT2) inhibitors, dapagliflozin, and empagliflozin, first developed as glucose-lowering agents for the treatment of Type 2 diabetes, have been demonstrated to improve prognosis in patients with heart failure and reduced ejection fraction (HFrEF) regardless of the presence of diabetes. Since these drugs have only recently been included among the four pillars of HFrEF treatment, cardiologists are still unfamiliar with their use in this setting. This article provides an up-to-date practical guide for the initiation and monitoring of patients treated with SGLT2 inhibitors.
Review on sodium-glucose cotransporter 2 inhibitor (SGLT2i) in diabetes mellitus and heart failure. [2020]SGLT-2 inhibitors are a novel class of anti-diabetic agents which act by inhibiting glucose reabsorption in proximal convoluted tubules of kidney. Apart from maintaining glucose homeostasis they exert a number of positive effects on the cardiovascular system like weight loss, decreasing blood pressure, preserving renal function, reducing triglycerides, natriuresis and improving endothelial dysfunction. In large clinical trials, all the three prototype agents - Empaglifozin, Canaglifozin and dapaglifozin have shown reductions in major adverse cardiovascular events including cardiovascular deaths, non fatal MI, stroke and heart failure (HF) hospitalizations. The reduction in heart failure hospitalization is a surprising finding and trials of these drug are now underway for HF also. More surprising is the fact that the benefits are comparable or even better that achieved by recently approved novel drugs for HF. In this review, we briefly discuss the pathophysiology of HF in diabetes, describe the prototype SGLT-2 molecules available, their data from large cardiovascular outcome trials till date and their role in current practice of diabetes management.
Eligibility of sodium-glucose co-transporter-2 inhibitors among patients with diabetes mellitus admitted for heart failure. [2021]Sodium-glucose co-transporter (SGLT)-2 inhibitors have been shown to reduce the risk of cardiovascular death and heart failure (HF) hospitalization in patients with type 2 diabetes mellitus (DM) and high cardiovascular risk in two large clinical outcome trials: empagliflozin in EMPA-REG OUTCOME and canagliflozin in CANVAS. The scope of eligibility for SGLT-2 inhibitors (empagliflozin and canagliflozin) among patients with type 2 DM and HF, based on clinical trial criteria and current US Food and Drug Administration (FDA) labelling criteria, remains unknown.
SGLT-2 Inhibitor Use in Heart Failure: A Review for Nurses. [2022]Sodium-glucose cotransporter-2 (SGLT-2) inhibitors (empagliflozin, canagliflozin, dapagliflozin, and ertugliflozin) are a new class of heart failure medications that have previously been exclusively utilized in the management of type 2 diabetes mellitus (T2DM). The rationale for using SGLT-2 inhibitors in patients with heart failure has stemmed from recent landmark clinical trials in T2DM in which reductions in mortality and hospitalization for heart failure were first observed. On the basis of these robust outcomes, empagliflozin has further been evaluated in heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction and dapagliflozin solely in the management of HFrEF. While cardiovascular outcomes among each agent vary depending on the patient population, updates among both the American and European guidelines have included SGLT-2 inhibitors as pillars of therapy. The exact mechanisms for how SGLT-2 inhibitors are beneficial in heart failure are unknown, but current hypotheses include multiple metabolic and hemodynamic mechanisms. The purpose of this review is to summarize available literature focusing on the use of the SGLT-2 inhibitors as adjunctive therapy in heart failure, as well as evaluate mechanisms for heart failure benefit, adverse effects, and practical considerations for using these agents in the clinical setting.
Comparing the clinical outcomes across different sodium/glucose cotransporter 2 (SGLT2) inhibitors in heart failure patients: a systematic review and network meta-analysis of randomized controlled trials. [2022]Empagliflozin, dapagliflozin, canagliflozin, and ertugliflozin have been shown in randomized controlled trials to improve cardiovascular, metabolic, and renal outcomes in heart failure patients. To date, there has not been any meta-analysis examining the differences in clinical outcomes across different SGLT2 inhibitors in heart failure patients.
[Practical considerations in the use of SGLT2 inhibitors in cardiovascular diseases]. [2021]Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a class of drugs which offer cardiovascular (CV) and renal benefits. They are currently indicated as first-line treatments of type 2 diabetes mellitus (T2DM) in patients with CV disease, high CV risk, renal disease, or heart failure with reduced ejection fraction (HFrEF). Two randomized clinical trials have shown the benefits of dapagliflozin and empagliflozin in patients with HFrEF, regardless of the presence of T2DM. Despite an overall favorable safety profile, attention has to be paid to adverse events, such as an increased risk of euglycemic diabetic ketoacidosis and genital mycotic infections. We present an up-to-date narrative literature review of the physiological mechanisms of action, current indications, and side effects of SGLT2 inhibitors.
SGLT2 Inhibitors, What the Emergency Physician Needs to Know: A Narrative Review. [2021]Canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin belong to a class of antidiabetic treatments referred to as sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors, or SGLT2is). SGLT2is are currently indicated in North America and in Europe in type 2 diabetes mellitus, especially in patients with cardiovascular (CV) disease, high CV risk, heart failure, or renal disease. In Europe, dapagliflozin is also approved as an adjunct to insulin in patients with type 1 diabetes mellitus. New data provide evidence for benefits in heart failure with reduced ejection fraction and chronic kidney disease, including in patients without diabetes. The use of SGLT2is is expected to increase, suggesting that a growing number of patients will present to the emergency departments with these drugs. Most common adverse events are easily treatable, including mild genitourinary infections and conditions related to volume depletion. However, attention must be paid to some potentially serious adverse events, such as hypoglycemia (when combined with insulin or insulin secretagogues), lower limb ischemia, and diabetic ketoacidosis. We provide an up-to-date practical guide highlighting important elements on the adverse effects of SGLT2is and their handling in some frequently encountered clinical situations such as acute heart failure and decompensated diabetes.
Safety profile of sodium glucose co-transporter 2 (SGLT2) inhibitors: A brief summary. [2022]A new therapeutic class of oral agents firstly used for the treatment of type 2 diabetes mellitus is represented by gliflozines or sodium-glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors might be effective alone or in combination with any other drugs. This therapeutic class currently includes five agents: canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, and sotagliflozin. SGLT2 inhibitors prevent the renal reabsorption of filtered glucose and sodium by blocking the SGLT2 co-transporters in the proximal convoluted renal tubule, facilitating glucose excretion in the urine (glycosuria) and lowering blood glucose levels. SGLT2 inhibitors have also shown to have pleiotropic effects and determine cardiovascular and renal prevention, thus leading to an extension of their therapeutic indication to include the heart failure. Despite their clinical benefits, warnings about adverse events have been implemented by Regulatory Agencies in the product's information since their introduction to the market. In particular, SGLT2 inhibitors have shown a strong impact on a high number of risk factors. They can cause hypoglycaemia, hypotension, lower limb amputation, fractures, genito-urinary infections, and diabetic ketoacidosis with different frequencies of onset. Despite some of these events are rare, they can lead to serious and dangerous complications, highlighting the importance of a strict monitoring of patients. Overall, SLGT-2 inhibitors are effective antidiabetic drugs with favorable advantages in renal and cardiovascular protection, and with a generally well-tolerated safety profile. This review aims to summarize the safety profile of SGLT2 inhibitors available in the market.
Safety of four SGLT2 inhibitors in three chronic diseases: A meta-analysis of large randomized trials of SGLT2 inhibitors. [2022]There are no relevant meta-analyses that have assessed the safety of the sodium-glucose transporter 2 (SGLT2) inhibitors in different chronic diseases. We aimed at evaluating the safety of four SGLT2 inhibitors in three chronic diseases by meta-analysis of the large randomized trials of SGLT2 inhibitors. We performed random-effects meta-analysis and carried out subgroup analysis according to type of underlying diseases and type of SGLT2 inhibitors. SGLT2 inhibitors versus placebo significantly reduced the risk of acute kidney injury (RR 0.75, 95% CI 0.66-0.85), and showed the reduced trend in the risk of severe hypoglycemia (RR 0.86, 95% CI 0.71-1.03). SGLT2 inhibitors significantly increased the risks of diabetic ketoacidosis (RR 2.57), genital infection (RR 3.75), and volume depletion (RR 1.14); and showed the increased trends in the risks of fracture (RR 1.07), amputation (RR 1.21), and urinary tract infection (RR 1.07). These effects exhibited by SGLT2 inhibitors were consistent across three chronic diseases (i.e. type 2 diabetes, chronic heart failure, and chronic kidney disease) and four SGLT2 inhibitors (i.e. dapagliflozin, empagliflozin, ertugliflozin, and canagliflozin) (all Psubgroup > 0.05). These findings will guide that specific adverse events are monitored when SGLT2 inhibitors are used in clinical practice.
Adverse events associated with sodium glucose co-transporter 2 inhibitors: an overview of quantitative systematic reviews. [2022]Multiple published quantitative systematic reviews have reported on adverse events associated with the use of sodium glucose co-transporter 2 (SGLT-2) inhibitors in patients with type 2 diabetes mellitus.
SGLT2 Inhibitors and Their Mode of Action in Heart Failure-Has the Mystery Been Unravelled? [2022]SGLT2 inhibitors (SGLT2i) are new drugs for patients with heart failure (HF) irrespective of diabetes. However, the mechanisms of SGLT2i in HF remain elusive. This article discusses the current clinical evidence for using SGLT2i in different types of heart failure and provides an overview about the possible underlying mechanisms.
Clinical pharmacology of SGLT-2 inhibitors in heart failure. [2023]Sodium-glucose cotransporter 2 (SGLT2) inhibitors constitute a class of oral antiglycemic agents that have emerged as a new therapeutic strategy for heart failure (HF) with reduced ejection fraction (HFrEF) and, potentially, for HF with preserved ejection fraction (HFpEF).
Mechanisms of SGLT2 Inhibitors in Heart Failure and Their Clinical Value. [2023]Sodium-glucose cotransporter 2 (SGLT2) inhibitors are widely used to treat diabetes mellitus. Abundant evidence has shown that SGLT2 inhibitors can reduce hospitalization for heart failure (HF) in patients with or without diabetes. An increasing number of studies are being conducted on the mechanisms of action of SGLT2 inhibitors in HF. Our review summarizes a series of clinical trials on the cardioprotective effects of SGLT2 inhibitors in the treatment of HF. We have summarized several classical SGLT2 inhibitors in cardioprotection research, including empagliflozin, dapagliflozin, canagliflozin, ertugliflozin, and sotagliflozin. In addition, we provided a brief overview of the safety and benefits of SGLT2 inhibitors. Finally, we focused on the mechanisms of SGLT2 inhibitors in the treatment of HF, including ion-exchange regulation, volume regulation, ventricular remodeling, and cardiac energy metabolism. Exploring the mechanisms of SGLT2 inhibitors has provided insight into repurposing these diabetic drugs for the treatment of HF.