Clinical trial NCT05897489: SGLT2 for Heart Failure in CHD Patients
Official title: SGLT2 Inhibitors in Adult Patients With Heart Failure Related to Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with heart failure and congenital heart disease

Brief summary: Heart failure (HF) in adult patients with congenital heart disease is a major cause of morbidity and mortality. Approximately 30% of patients with significant congenital heart disease will develop signs of heart failure. Heart failure leads to hospitalization and disability with a longer hospital stay and higher health care costs as compared to heart failure patients without congenital heart disease. One-third of deaths in patients with congenital heart disease are attributable to heart failure.

In patients with heart failure and reduced ejection fraction (EF), 2021 ESC recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) (dapaglifozin and empaglifozin), a new therapeutic class for heart failure (HF), in a class IA recommendation. In addition to reduced EF, these molecules have shown efficacy in preserved EF, leading to their reimbursement in both preserved and reduced ejection fraction in France.

Unfortunately, given the relatively low number of HF-congenital heart disease, patients, they were not included in previous studies. However, the seriousness of their condition and the absence of therapeutic explain the prescription of SGLT2i in those patients and the likelihood of increased use in the future. This especially underlines the need for safety data in this real-world population.

To date, no data on the safety or efficacy of SGLT2i in HF-congenital heart disease have been published. The results of this study would provide reassurance about the safety of SGLT2i in adult congenital patients and potentially expand the indication of SGLT2i in HF related to congenital heart disease

The objective of this study is to assess on real-life data, through a multicenter registry:

* The efficacy of SGLT2i in patients with heart failure related to congenital heart disease - The indications of SGLT2i use (type of congenital heart disease)
* The safety of SGLT2i (collection of adverse events)


Eligibility 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

Primary outcomes:
measure: To evaluate, on real-life data, the efficacy of iSGLT2 in patients with heart failure related to congenital heart disease as defined by improvement in NYHA class and/or change in NT-proBNP.
timeFrame: 6 to 12 months after SGLT2i introduction
Secondary outcomes:
measure: To describe the population of adults with congenital heart disease on SGLT2i prescription
timeFrame: 6-12 months after SGLT2i introduction
measure: To compare the evolution of biological stress test parameters of SGLT2i in patients with heart failure related to congenital heart disease treated with iSGLT2.
timeFrame: 6-12 months after SGLT2i introduction
measure: Incidence of Treatment-Emergent Adverse Event in patients with heart failure related to congenital heart disease.[Safety and Tolerability]
timeFrame: 6-12 months after SGLT2i introduction
measure: To evaluate the overall survival of heart failure related to congenital heart disease patients on SGLT2i after 12 months
timeFrame: 6-12 months after SGLT2i introduction
Other outcomes:
Locations:
city: Nice
country: France
facility: University hospital of Nice
Study officials:
References: