Empagliflozin 10 MG for Ascites

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University Digestive Health Clinic, Redwood City, CA
Ascites+5 More
Empagliflozin 10 MG - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether empagliflozin can be used to treat ascites in patients with liver cirrhosis.

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Eligible Conditions

  • Ascites
  • Sodium-Glucose Transporter 2 Inhibitors
  • Liver Cirrhosis
  • Cirrhosis of the Liver
  • Hepatic Ascites

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Empagliflozin 10 MG will improve 1 primary outcome and 4 secondary outcomes in patients with Ascites. Measurement will happen over the course of Baseline to 12 weeks.

Baseline to 12 weeks
Estimated glomerular filtration rate as a measure of kidney function
Mean change in abdominal girth from baseline to 12 weeks
Mean change in body weight from baseline to 12 weeks
Mean change in patient reported functional status
Participant retention rate as a measure of study feasibility

Trial Safety

Side Effects for

Empagliflozin
Renal/Urinary
38%
Musculoskeletal
33%
Metabolic
23%
Cardiovascular
23%
Other
15%
Gastrointestinal
15%
Worsening Heart Failure
8%
Respiratory
8%
Worsening Renal Function
3%
Angioedema
3%
S. Aureus Bacteremia
3%
Acute Kidney Injury
3%
Syncope
3%
Atrial Fibrillation
0%
Respiratory Failure
0%
Hypovolemic shock
0%
Delirium
0%
Heart Failure
0%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03200860) in the Empagliflozin ARM group. Side effects include: Renal/Urinary with 38%, Musculoskeletal with 33%, Metabolic with 23%, Cardiovascular with 23%, Other with 15%.

Trial Design

1 Treatment Group

Empagliflozin 10mg PO daily for 12 weeks
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. Empagliflozin 10 MG is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Empagliflozin 10mg PO daily for 12 weeks
Drug
Single arm trial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 12 weeks for reporting.

Who is running the study

Principal Investigator
A. G.
Aparna Goel, Protocol Director
Stanford University

Closest Location

Stanford University Digestive Health Clinic - Redwood City, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
in the absence of alternative identifiable causes Diuretic-resistant ascites is defined as one of the following: -An inability to mobilize ascites despite adherence to dietary sodium restriction (2000 mg per day) and administration of maximum tolerable doses of oral diuretics; -Rapid reaccumulation of fluid after therapeutic paracentesis despite adherence to a sodium-restricted diet; -Development of diuretic-related complications such as progressive azotemia, hepatic encephalopathy, or progressive electrolyte imbalances in the absence of alternative identifiable causes. show original
is a complication of end-stage liver disease show original
are important factors that contribute to a study participant's decision to enroll in a particular study show original

Patient Q&A Section

What is ascites?

"Ascites can be caused by either intra-abdominal or pleural fluid shifts. A high level of protein in the ascites, serum total protein >30g/dl, is indicative of more advanced ascites. If the ascites contain high levels of albumin, neovenous fluid can be assumed to be due to portal vein thrombosis, while low levels with low albumin or protein-rich ascites is indicative of malignancy; both ascites and retro-peritoneal fluid can be sampled for protein analysis. In all, protein levels should be evaluated in ascites." - Anonymous Online Contributor

Unverified Answer

What are the signs of ascites?

"The presence of blood, mucus or protein, together with symptoms of pain or fatigue should raise the possibility of an ascites. However, a diagnostic fluid study (serum total and differential protein, urea) is required to rule out fluid overload." - Anonymous Online Contributor

Unverified Answer

Can ascites be cured?

"There is no cure for ascites and symptom control is the focus of treatment. Patients suffering from ascites should therefore be advised to get involved in active exercise, a low-fat diet and regular exercise for optimal symptom control." - Anonymous Online Contributor

Unverified Answer

How many people get ascites a year in the United States?

"The number of people with ascites may be increasing. This may be a result of people with chronic liver disease having a higher risk of developing ascites." - Anonymous Online Contributor

Unverified Answer

What causes ascites?

"Causes of ascites can be classified into infectious and noninfectious diseases. Infectious causes are more frequently found in children. In patients with acute liver failure, viral serology can help identify the cause of ascites and help guide therapy; however, other causes of ascites must be considered in patients with chronic liver failure. Clinicians could be more proactive in investigating ascites in patients who are critically unwell because initial investigations can lead to an urgent diagnosis and therapy, especially in children." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ascites?

"Bacterial infections, particularly pneumonia, or ascitic fluid is frequently diagnosed only when ascites is found in association with medical problems or in those with poor performance status. Treatment for ascites is usually directed at the underlying cause. Antibiotics and antimalaria medication will be taken only in patients with persistent or recurrent symptoms and ascites despite adequate medical treatments." - Anonymous Online Contributor

Unverified Answer

How does empagliflozin 10 mg work?

"EMPA (10 mg) plus MET were as effective as MET alone in terms of reducing mean SBP, DBP, and DBP. Neither EMPA 10 mg nor MET alone decreased 24-hour urinary albumin excretion (UAE). It appears like the mechanism of action of EMPA and EMPA/MET are to reduce blood pressure rather than to change albumin excretion. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6535991/)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving empagliflozin 10 mg?

"Empagliflozin may be an effective adjunct for treating patients with cirrhosis and portal hypertension associated with refractory ascites; however, further clinical studies are needed in patients with decompensated ascites." - Anonymous Online Contributor

Unverified Answer

Does empagliflozin 10 mg improve quality of life for those with ascites?

"Empagliflozin, compared with placebo, was well tolerated by patients with ascites; empagliflozin improved key domains of quality of life and reduced the impact of ascites on health-related quality of life." - Anonymous Online Contributor

Unverified Answer

Is empagliflozin 10 mg safe for people?

"Empagliflozin 10 mg was well tolerated by patients with type 2 diabetes inadequately controlled on the initial prescription and achieved similar HbA1c reductions to those previously reported for once-daily dosing of empagliflozin 10 and/or 5 mg." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for ascites?

"There are no clear indications which individuals should consider clinical trials for ascites from their medical or paramedical history. There are however specific criteria which must be met." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of empagliflozin 10 mg?

"Recent findings of this pilot study reveal substantial safety concerns regarding empagliflozin therapy. The use of weight-adjusted doses of empagliflozin had no significant impact on side effects. It was hypothesized that the lack of empagliflozin impact on weight is due to its potent blood pressure lowering effects." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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