Congenital Heart Disease study: Empagliflozin
Official title SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure
ClinicalTrials.gov ID: NCT06955260
What this study is testing
What is Empagliflozin 10 mg?
This is an investigational pill being studied to see if it can help people with a specific heart condition called Fontan Circulatory Failure. It is designed to help the kidneys remove extra sugar and salt from the body through urine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the medication empagliflozin can help people with Fontan Circulatory Failure have a better quality of life.
- Who it's for
- The study is looking for people born with a heart defect who have only one working lower chamber and have developed Fontan Circulatory Failure.
- What's involved
- Participants will take empagliflozin and undergo tests to check how their heart is working and how they feel during daily activities.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults (≥18 years of age) with FCF, defined by dysfunction of the Fontan physiology that causes limitation to the individual's ability to carry out...
You likely can't join if
- Diuretic initiation or dose change ≤2 weeks prior to enrollment On a SGLT2 inhibitor currently or within 12-weeks prior to enrollment in the trial
- Allergic to or has a known intolerance to any of the ingredients in empagliflozin or other SGLT2 inhibitors
- Pregnant or planning a pregnancy during the duration of the trial or breast feeding
- Living with type 1 diabetes mellitus
- Has an unresolved acute illness (e.g., acute appendicitis, COVID-19, gastroenteritis)
- History of ketoacidosis
See the full eligibility criteria
- Adults (≥18 years of age) with FCF, defined by dysfunction of the Fontan physiology that causes limitation to the individual's ability to carry out daily life activities, on standard of care therapy
- Diuretic initiation or dose change ≤2 weeks prior to enrollment On a SGLT2 inhibitor currently or within 12-weeks prior to enrollment in the trial
- Allergic to or has a known intolerance to any of the ingredients in empagliflozin or other SGLT2 inhibitors
- Pregnant or planning a pregnancy during the duration of the trial or breast feeding
- Living with type 1 diabetes mellitus
- Has an unresolved acute illness (e.g., acute appendicitis, COVID-19, gastroenteritis)
- History of ketoacidosis
- Has an estimated glomerular filtration rate (eGFR) that is \<30 mL/min/1.73 m2 Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2-fold upper limit of normal (ULN) at screening
- Has a baseline systolic BP that is \<80 mmHg or ≥200 mmHg
- Admission for intravenous diuretics
- Admission for intravenous inotropes
- Admission for ascites drainage
- Admission for new or worsening ascites of clinical significance
- Admission for management of arrhythmia
- Admission for management of lymphatic dysfunction
- Admission for treatment cardiological or cardiac surgical procedure within 30-days prior to screening, or consideration for any cardiac surgical or treatment cardiological procedure during trial participation
- Admission for cardiac resynchronization therapy within 90-days prior to screening, or consideration of cardiac resynchronization therapy during trial participation
- Is unable to provide written informed consent, complete the trial or comply with the requirements of the trial protocol
- Participation in other treatment studies within 30-days of the screening visit that could influence any of the trial outcomes (exclusive of observational registries)
- Received intravenous diuretic within the previous 14-days
- On a heart transplant waiting list
- Current or imminent hospitalization for management of FCF
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.