Dapagliflozin in Adult Patients with Failing Fontan (DAPA-FONTAN): A Prospective Multicentre Study - 04/09/25
, Victor Waldmann 1, Valentin Baland 2, Elise Barre 3, Jelena Radojevic 4, Laurianne Le Gloan 5, Patrice Guérin 6, Fabien Labombarda 7, Fanny Dion 8, Reaksmei Ly 9, François Godart 10, Pamela Moceri 11, Pauline David 1, Alexis Barat 1, Antoine Legendre 1, Anne-Solene Chaussade 1, Sebastien Hascoet 12, Laurence Iserin 13
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Abstract |
Introduction |
Heart failure (HF) is the leading cause of death in adults with congenital heart disease, particularly in patients with a univentricular heart and Fontan circulation. Over time, this circulation is associated with increasing morbidity, especially in cases of circulatory failure (Failing Fontan–FF). FF has multiple causes: systolic or diastolic dysfunction of the single ventricle, elevated pulmonary vascular resistance, significant valve regurgitation, or stenoses within the Fontan circuit. Therapeutic options are limited, and Dapagliflozin—currently recommended for left-sided HF—may offer functional benefits in this specific population.
Objective |
To assess the impact of Dapagliflozin on functional capacity in adult patients with FF due to systolic or diastolic dysfunction.
Methods |
A 6-month prospective, multicenter, observational study.Inclusion criteria include adults older than 18 years with FF confirmed by right heart catheterization within the past 6 months, defined by:
– Systolic dysfunction with single ventricular ejection fraction (EF)≤40% and ventricular end-diastolic pressure (VEDP) or pulmonary artery wedge pressure (PAWP)≥15mmHg.
– Diastolic dysfunction with EF≥41% and VEDP or PAWP≥15mmHg.Exclusion criteria include severe atrioventricular valve regurgitation, elevated pulmonary vascular resistance, Fontan circuit stenosis, pregnancy, eGFR<25ml/min/1.73 m2, and systolic BP<95mmHg.Primary endpoint: Change in VO2 max on cardiopulmonary exercise testing (CPET) between baseline and 6 months.Secondary endpoints: NYHA class, quality of life (KCCQ-12), NT-proBNP levels, EF, number of HF-related hospitalizations, diuretic dosage, liver and kidney function, blood pressure, and adverse events.
Expected Results |
An improvement in exercise capacity, NYHA class, quality of life, and biological parameters is expected, with good clinical and biological tolerance of the treatment.
Perspectives |
This study may support the targeted use of Dapagliflozin in FF patients with systolic or diastolic dysfunction and lay the groundwork for future randomized trials in this high-risk population.
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Vol 118 - N° 8-9S
P. S251-S252 - septembre 2025 Retour au numéro
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