What is the mechanism of action of this treatment?

SGLT2 inhibitors, such as dapagliflozin, work by preventing the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine. This not only helps in controlling blood glucose levels but also has beneficial effects on heart failure by reducing blood pressure, decreasing fluid overload, and improving cardiac function. Other common treatments for heart failure include ACE inhibitors, which relax blood vessels and reduce the workload on the heart, and beta-blockers, which slow the heart rate and decrease blood pressure. These mechanisms are crucial for heart failure patients as they help to alleviate symptoms, improve quality of life, and reduce the risk of hospitalization and mortality.

What side effects are associated with this type of intervention?

SGLT2 inhibitors, such as dapagliflozin, are commonly used in the treatment of heart failure and have several known side effects. These include an increased risk of urinary tract infections and genital mycotic infections due to higher glucose concentrations in the urine. Patients may also experience dehydration, leading to dizziness or hypotension, especially in those with low blood pressure or on diuretics. Additionally, there is a risk of diabetic ketoacidosis, even in patients with type 2 diabetes. Other common treatments for heart failure, such as ACE inhibitors and beta-blockers, can cause side effects like cough, elevated potassium levels, and bradycardia, respectively.

What prior FDA approvals exist?

The FDA has approved several SGLT2 inhibitors for the treatment of heart failure. Dapagliflozin, an SGLT2 inhibitor, has been studied for its effects on heart and lung function in patients with chronic kidney disease and has shown cardiovascular benefits. Other SGLT2 inhibitors, such as empagliflozin and canagliflozin, have also demonstrated benefits in reducing heart failure-related outcomes. These drugs work by preventing glucose reabsorption in the kidneys, which not only helps in glycemic control but also provides cardiovascular and renal benefits.

What other types of research exist?

Promising alternatives to Dapagliflozin for heart failure patients include other SGLT2 inhibitors like Empagliflozin and Canagliflozin, which have demonstrated cardiovascular benefits. Additionally, GLP-1 receptor agonists such as Liraglutide, Semaglutide, and Dulaglutide have shown favorable outcomes in reducing cardiovascular events and may be considered as novel alternatives.

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Dapagliflozin for Chronic Kidney Disease

Phase 1 & 2

Recruiting

Led By Rupal Mehta, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Evidence of subclinical heart failure with preserved ejection fraction at their pre-exercise echocardiogram (defined as meeting any of the American Society of Echocardiography (ASE) criteria for diastolic dysfunction [septal e'<7 cm/wc, average E/e' ratio>14, left atrial volume index >34 mL/m2, and peak TR velocity >2.8 m/sec] or absolute left ventricular longitudinal strain < 18%)

>18 years of age

Must not have

active cancer

baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction </= 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing dapagliflozin, a medication that helps remove sugar from the body through urine, in patients with chronic kidney disease and early heart failure. The study aims to see if this medication can improve their heart and lung function by lowering blood sugar levels. Dapagliflozin was initially approved for type 2 diabetes and later found to reduce cardiovascular and kidney problems.

Who is the study for?

This trial is for adults over 18 with chronic kidney disease who are on stable heart medication, have signs of a specific type of heart failure but no symptoms, and an eGFR between 25-60. It's not for those with liver disease, recent heart procedures, extreme blood pressure levels, pregnancy, certain systemic diseases like amyloidosis or sarcoidosis, diabetes, severe lung disease requiring oxygen therapy or significant chest pain.

What is being tested?

The study tests the effects of Dapagliflozin (Farxiga), a drug that affects sugar transport in kidneys when added to standard care. It focuses on how this drug influences heart and lung function as well as metabolites in patients with chronic kidney disease.

What are the potential side effects?

While the information provided does not specify side effects for Dapagliflozin in this context directly, common ones may include dehydration leading to low blood pressure; genital yeast infections; urinary tract infections; increased urination; and potential risk of diabetic ketoacidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart test shows early signs of heart failure but it can still pump well.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have active cancer.

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My heart pumps less blood than normal.

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I do not have any chronic conditions that would prevent me from completing heart tests.

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I have heart issues that haven't been treated with surgery.

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I have a serious heart valve problem.

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I am currently taking medication for diabetes that includes SGLT2 inhibitors.

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I am on immunosuppressive therapy.

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I have a liver condition.

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I have a condition like amyloidosis or sarcoidosis that can lead to heart failure.

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I experience symptoms of heart failure.

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I have diabetes or have had it in the past.

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I need home oxygen for my lung condition.

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I experience chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Circulating plasma metabolite concentrations

Left ventricular longitudinal strain (LVLS)

Peak VO2 (oxygen consumption)

Secondary study objectives

Left Atrial Reservoir Strain (LARS)

Right ventricular free wall strain

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Thirty individuals will be randomized to dapagliflozin 10mg to be taken daily for six months.

Group II: Standard of Care groupActive Control1 Intervention

Thirty individuals will be randomized to standard of care treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dapagliflozin 10 MG [Farxiga]

2021

Completed Phase 2

~20

0 / 15Eligibility criteria met

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

SGLT2 inhibitors, such as dapagliflozin, work by preventing the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine. This not only helps in controlling blood glucose levels but also has beneficial effects on heart failure by reducing blood pressure, decreasing fluid overload, and improving cardiac function. Other common treatments for heart failure include ACE inhibitors, which relax blood vessels and reduce the workload on the heart, and beta-blockers, which slow the heart rate and decrease blood pressure. These mechanisms are crucial for heart failure patients as they help to alleviate symptoms, improve quality of life, and reduce the risk of hospitalization and mortality.