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
Research Team
MB
Mark Belkin, MD
Principal Investigator
University of Chicago
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 Canada, Japan for the following indications:
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 Chicago
Lead Sponsor
Trials
1086
Patients Recruited
844,000+
Findings from Research
SGLT2 inhibitors, such as dapagliflozin and empagliflozin, not only lower blood sugar but also significantly improve outcomes for patients with heart failure and reduced ejection fraction (HFrEF), even in those without diabetes.
These medications have recently been recognized as essential components of HFrEF treatment, and this article serves as a practical guide for cardiologists on how to start and monitor patients on SGLT2 inhibitors.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
ANMCO statement on the use of sodium-glucose cotransporter 2 inhibitors in patients with heart failure: a practical guide for a streamlined implementation.Di Fusco, SA., Gronda, E., Mocini, E., et al.[2022]
SGLT-2 inhibitors, a new class of diabetes medications, not only help control blood sugar levels but also provide significant cardiovascular benefits, including weight loss, lower blood pressure, and improved kidney function.
Large clinical trials have shown that SGLT-2 inhibitors like Empagliflozin, Canagliflozin, and Dapagliflozin reduce major cardiovascular events, including heart failure hospitalizations, suggesting they may be effective treatments for heart failure as well.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Review on sodium-glucose cotransporter 2 inhibitor (SGLT2i) in diabetes mellitus and heart failure.Pradhan, A., Vohra, S., Vishwakarma, P., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Eligibility of sodium-glucose co-transporter-2 inhibitors among patients with diabetes mellitus admitted for heart failure.Sharma, A., Wu, J., Ezekowitz, JA., et al.[2021]
SGLT-2 inhibitors, originally used for type 2 diabetes, have been shown to significantly reduce mortality and hospitalization rates in heart failure patients, leading to their inclusion as essential treatments in recent American and European guidelines.
While the exact mechanisms of how SGLT-2 inhibitors improve heart failure outcomes are not fully understood, they are believed to involve various metabolic and hemodynamic effects, highlighting their potential as adjunctive therapy in managing heart failure.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
SGLT-2 Inhibitor Use in Heart Failure: A Review for Nurses.March, KL., Lukas, JG., Berei, TJ., et al.[2022]
A meta-analysis of 10 randomized controlled trials involving 15,373 heart failure patients found no significant differences in clinical outcomes among the SGLT2 inhibitors empagliflozin, dapagliflozin, canagliflozin, and ertugliflozin regarding heart failure hospitalizations, cardiovascular deaths, and all-cause mortality.
Despite the lack of differences in treatment effects, the analysis highlighted the need for further research due to the variability in study results and the wide confidence intervals observed.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.Teo, YH., Yoong, CSY., Syn, NL., et al.[2022]
SGLT2 inhibitors, like dapagliflozin and empagliflozin, are effective first-line treatments for type 2 diabetes, especially in patients with cardiovascular disease or heart failure, showing benefits even in those without diabetes.
While SGLT2 inhibitors have a generally favorable safety profile, they can increase the risk of euglycemic diabetic ketoacidosis and genital infections, which requires careful monitoring in patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Practical considerations in the use of SGLT2 inhibitors in cardiovascular diseases].Lu, H., Hullin, R., Yerly, P., et al.[2021]
SGLT2 inhibitors, including canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin, are effective treatments for type 2 diabetes and have shown benefits in heart failure and chronic kidney disease, even in patients without diabetes.
While most side effects of SGLT2 inhibitors, like mild genitourinary infections, are manageable, healthcare providers should be cautious of serious risks such as hypoglycemia, lower limb ischemia, and diabetic ketoacidosis, especially when these drugs are used with insulin.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
SGLT2 Inhibitors, What the Emergency Physician Needs to Know: A Narrative Review.Lu, H., Lu, H., Kosinski, C., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety profile of sodium glucose co-transporter 2 (SGLT2) inhibitors: A brief summary.Mascolo, A., Di Napoli, R., Balzano, N., et al.[2022]
SGLT2 inhibitors significantly reduce the risk of acute kidney injury (RR 0.75) and show a trend towards lower severe hypoglycemia risk (RR 0.86), indicating a safety benefit in patients with chronic diseases.
However, SGLT2 inhibitors are associated with increased risks of diabetic ketoacidosis (RR 2.57), genital infections (RR 3.75), and volume depletion (RR 1.14), suggesting that these specific adverse events should be closely monitored in clinical practice.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety of four SGLT2 inhibitors in three chronic diseases: A meta-analysis of large randomized trials of SGLT2 inhibitors.Qiu, M., Ding, LL., Zhang, M., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Adverse events associated with sodium glucose co-transporter 2 inhibitors: an overview of quantitative systematic reviews.Pelletier, R., Ng, K., Alkabbani, W., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
SGLT2 Inhibitors and Their Mode of Action in Heart Failure-Has the Mystery Been Unravelled?Pabel, S., Hamdani, N., Luedde, M., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical pharmacology of SGLT-2 inhibitors in heart failure.Velliou, M., Polyzogopoulou, E., Ventoulis, I., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Mechanisms of SGLT2 Inhibitors in Heart Failure and Their Clinical Value.Xie, Y., Wei, Y., Li, D., et al.[2023]
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]
Review on sodium-glucose cotransporter 2 inhibitor (SGLT2i) in diabetes mellitus and heart failure. [2020]
Eligibility of sodium-glucose co-transporter-2 inhibitors among patients with diabetes mellitus admitted for heart failure. [2021]
SGLT-2 Inhibitor Use in Heart Failure: A Review for Nurses. [2022]
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]
[Practical considerations in the use of SGLT2 inhibitors in cardiovascular diseases]. [2021]
SGLT2 Inhibitors, What the Emergency Physician Needs to Know: A Narrative Review. [2021]
Safety profile of sodium glucose co-transporter 2 (SGLT2) inhibitors: A brief summary. [2022]
Safety of four SGLT2 inhibitors in three chronic diseases: A meta-analysis of large randomized trials of SGLT2 inhibitors. [2022]
Adverse events associated with sodium glucose co-transporter 2 inhibitors: an overview of quantitative systematic reviews. [2022]
SGLT2 Inhibitors and Their Mode of Action in Heart Failure-Has the Mystery Been Unravelled? [2022]
Clinical pharmacology of SGLT-2 inhibitors in heart failure. [2023]
Mechanisms of SGLT2 Inhibitors in Heart Failure and Their Clinical Value. [2023]