What is the mechanism of action of this treatment?

Common treatments for heart failure include SGLT-2 inhibitors like empagliflozin, which reduce blood pressure and blood volume through diuretic effects, and modulate sympathetic and neuro-hormonal activation. ACE inhibitors and ARBs lower blood pressure and reduce strain on the heart by inhibiting the renin-angiotensin system. Beta blockers decrease heart rate and myocardial oxygen demand, improving heart function. Diuretics help remove excess fluid, reducing symptoms of congestion. These mechanisms are crucial for heart failure patients as they alleviate symptoms, improve quality of life, and reduce morbidity and mortality.

What side effects are associated with this type of intervention?

Common treatments for heart failure, such as SGLT-2 inhibitors like Empagliflozin, can cause side effects including urinary tract infections, genital mycotic infections, and dehydration due to their diuretic effects. Beta blockers may lead to fatigue, bradycardia, and hypotension. ACE inhibitors and ARBs can cause hyperkalemia, cough, and angioedema. Mineralocorticoid receptor antagonists (MRAs) like spironolactone and eplerenone may result in hyperkalemia and, less commonly, gynecomastia. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Empagliflozin, a Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitor, has been approved by the FDA for the treatment of heart failure due to its cardiovascular benefits, including diuretic effects, increased blood volume, decreased blood pressure, and changes in sympathetic and neuro-hormonal activation. Other SGLT-2 inhibitors, such as canagliflozin and dapagliflozin, have also been approved for similar indications. These drugs have shown consistent benefits in reducing cardiovascular and all-cause mortality in patients with heart failure, with or without diabetes.

What other types of research exist?

Promising alternatives to Empagliflozin for heart failure patients include ARNI (sacubitril-valsartan), beta blockers (carvedilol, metoprolol succinate, bisoprolol), mineralocorticoid receptor antagonists (eplerenone, spironolactone), and soluble guanylate cyclase stimulators (vericiguat). These medications have shown efficacy in improving cardiovascular outcomes, reducing hospitalizations, and enhancing quality of life in heart failure patients.

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SGLT-2 Inhibitor

Empagliflozin for Heart Failure

Phase 4

Waitlist Available

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial tests empagliflozin in patients with HFpEF to see if it can improve their heart function and exercise ability by reducing fluid buildup and lowering pressures in the heart and lungs. Previous studies have shown that empagliflozin significantly improves outcomes in patients with HFpEF.

Who is the study for?

Adults aged 50-85 with clinical heart failure and a preserved ejection fraction (EF) over 50% can join this trial. It's not for those who've had bad reactions to SGLT-2 inhibitors, are already on such treatments, have severe kidney issues, unstable heart artery disease, serious irregular heartbeat problems, extreme obesity or can't exercise.

What is being tested?

The study is testing the effects of Empagliflozin on people with heart failure who still have good pumping function. Participants will take the drug daily for 12 weeks and undergo tests to see if it improves their fitness level and lowers pressure in the blood vessels of their lungs during exercise.

What are the potential side effects?

Empagliflozin may cause urinary tract infections, dehydration leading to low blood pressure, ketoacidosis (a serious condition related to diabetes), genital yeast infections in women and men, increased cholesterol levels, joint pain and allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

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

Treatment Details

Study Objectives

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

Primary study objectives

Peak Oxygen Uptake

Peak Pulmonary Capillary Wedge Pressure (PCWP)

Secondary study objectives

Diastolic parameters at rest and during submaximal exercise

Hemoglobin mass, plasma volume, total blood volume

Left ventricular volumes at rest and during submaximal exercise

+1 more

Side effects data

From 2019 Phase 2 trial • 80 Patients • NCT03200860

38%

Renal/Urinary

33%

Musculoskeletal

23%

Cardiovascular

23%

Metabolic

15%

Gastrointestinal

15%

Other

Worsening Heart Failure

Respiratory

Worsening Renal Function

S. Aureus Bacteremia

Angioedema

Acute Kidney Injury

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Empagliflozin

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

This arm of the study will take 10 mg empagliflozin daily for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include SGLT-2 inhibitors like empagliflozin, which reduce blood pressure and blood volume through diuretic effects, and modulate sympathetic and neuro-hormonal activation. ACE inhibitors and ARBs lower blood pressure and reduce strain on the heart by inhibiting the renin-angiotensin system. Beta blockers decrease heart rate and myocardial oxygen demand, improving heart function. Diuretics help remove excess fluid, reducing symptoms of congestion. These mechanisms are crucial for heart failure patients as they alleviate symptoms, improve quality of life, and reduce morbidity and mortality.

Renoprotective effects of empagliflozin in type 1 and type 2 models of diabetic nephropathy superimposed with hypertension.