RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Empagliflozin 10 mg for Congenital Heart Disease

Q: Is NCT06955260 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06955260?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06955260?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart. This condition can be initially managed with a Fontan operation, but there is a risk of developing Fontan Circulatory Failure (FCF) later in life.

Official registry: https://clinicaltrials.gov/study/NCT06955260 · Subodh Verma · enrollment listed as 410

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Empagliflozin 10 mg, or Placebo. The registry lists allocation as randomized. Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart.

They plan to enroll about 410 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized Trial of SGLT2 Inhibition With Empagliflozin in Adults With Fontan Circulatory Failure (EMPA-HEART 3 CardioLink-12)

Interventions: Empagliflozin 10 mg, Placebo

Primary outcome (registry wording): Hierarchical endpoint

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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

Public study contact (from the registry)

Nicole Cooke, CCRP

416-864-6060

Nicole.cooke@unityhealth.to

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

St. Paul's Hospital — Vancouver, British Columbia, Canada (recruiting)
University Health Network — Toronto, Ontario, Canada (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Re…

We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.

NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia

Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT06955260 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06955260?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06955260?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary