Using SGLT2 inhibitors for heart failure in patients with congenital heart disease
SGLT2 Inhibitors in Adult Patients With Heart Failure Related to Congenital Heart Disease
This study is testing if a new type of heart medication called SGLT2 inhibitors can help adults with congenital heart disease and heart failure feel better and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT05897489 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients with congenital heart disease who are experiencing heart failure. It aims to evaluate the effectiveness of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in managing heart failure symptoms and improving patient outcomes. The study includes patients who have initiated SGLT2i therapy within the last year or are starting it at the time of the visit, specifically targeting those with NYHA class II, III, or IV heart failure. The research is conducted at the University Hospital of Nice, leveraging the French social security system for patient registration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with congenital heart disease and clinical heart failure classified as NYHA class II, III, or IV.
Not a fit: Patients who oppose the use of their data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve heart failure management and outcomes for patients with congenital heart disease.
How similar studies have performed: While SGLT2 inhibitors have shown promise in heart failure management, this specific application in congenital heart disease is relatively novel and less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age * Congenital heart disease (repaired, unrepaired, or palliated) with clinical heart failure NYHA class II, III, or IV at the time of SGLT2i initiation B59 * Patient in whom SGLT2i therapy has been started within the previous 12 months or is started at the time of the visit. * Registered to the French social security system Exclusion Criteria: * Opposition of the patient to the use of his/her data
Where this trial is running
Nice
- University hospital of Nice — Nice, France (Recruiting)
Study contacts
- Study coordinator: Pamela MOCERI
- Email: moceri.p@chu-nice.fr
- Phone: 0492037733
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.