An observational study in Heart Failure, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
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:
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with heart failure and congenital heart disease
Exclusion Criteria:
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.
Efficacy of SGLT2i therapy will be assessed by a composite endpoint including NT-proBNP and NYHA class. Thus, a patient with any improvement (decrease) in the biomarker (NT-proBNP) and/or improvement in at least 1 NYHA class will be defined as successful with SGLT2i therapy. The success rate in the target population will be calculated at the end of the study follow-up
Time frame: 6 to 12 months after SGLT2i introduction
To describe the population of adults with congenital heart disease on SGLT2i prescription
The study population will be described by the history of the disease in particular duration of the evolution of the CI
Time frame: 6-12 months after SGLT2i introduction
To compare the evolution of biological stress test parameters of SGLT2i in patients with heart failure related to congenital heart disease treated with iSGLT2.
The evolution of the following efficacy parameters between baseline and M6/M12 will be studied : biological parameters (Plasma creatinine at T0 and 6-12 months, Kalemia at T0 and 6-12 months)
Time frame: 6-12 months after SGLT2i introduction
Incidence of Treatment-Emergent Adverse Event in patients with heart failure related to congenital heart disease.[Safety and Tolerability]
Tolerance will be studied through the collection of the following adverse events: arterial hypotension (BP will be recorded at M0, M6 and M12), hyperkalemia, acute renal failure, recurrent urinary tract infections, ketoacidosis (Discontinuation of treatment for AEs, Cardiovascular hospitalization during the study period, Cardiac transplantation or ventricular assist during the study period)
Time frame: 6-12 months after SGLT2i introduction
To evaluate the overall survival of heart failure related to congenital heart disease patients on SGLT2i after 12 months
Overall survival will be assessed at 6 months and 12 months after initiation of treatment. Survival time will be defined as the time in months from initiation of glifozine to death from any cause. Patients who discontinue follow-up before the end of the study follow-up period will be censored at the time of last report.
Time frame: 6-12 months after SGLT2i introduction
Plan to share: No
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Centre Hospitalier Universitaire de Nice